Sound Off: Users of Downgraded Concerta Generics


Generic Concerta Users Sound off

These first-person stories from generic Concerta users recount the dramatic and adverse changes they experienced—often not knowing why . This started around 2015.  Typically, those associating their devolved functioning with the different-looking “Concerta” pill were talked out of it by their pharmacists and/or physicians: “Generic is same as brand!”  Except they are wrong.

Even though ADHD Roller Coaster readers and others  successfully lobbied the FDA to downgrade these inferior generics, an election happened in 2016. Trump’s appointed FDA chief, Bob Gottlieb, came from the Heritage Foundation. During his short tenure, he pushed through dozens of generics. This was against FDA scientists’ concerns about lack of bioequivalency. In short, the generic should work the same as the brand, and they don’t.

By now, July 2021, I can’t even keep up with the inferior Concerta generics being loosed on a vulnerable public.  I do try, though, at this post, along with offering advice on how to get the authorized-generic (brand sold as a generic): Authorized Generic Concerta Update

These first-person stories remain important reminders of what happens when a stimulant medication that works well suddenly doesn’t—due to switching to the generic.

The Problem with Concerta Generics?

What problem was/is there, exactly?  That’s easy. These generics lack the essential technology that makes Concerta, Concerta (the novel and proprietary OROS osmotic pump).

Many medications contain the same stimulant methylphenidate (MPH). That includes Concerta, Ritalin, Ritalin LA, Daytrana, Focalin (a variant of MPH), Metadate, and Quillivant.  The difference is in how the MPH is delivered to the system.

My post linked to above explains in detail why the generics don’t work as the brand Concerta does.

In this post, below, you will find a compilation of real stories from generic Concerta users, via comments to my blog posts on this topic. They share their experiences with the Concerta “true generics.” As it turns out, they weren’t all that true to brand.

To “Big Generic” and Pharmacists

I invite the shareholders of the companies who manufactured and sold these inferior products to read these stories of lives going off the rails.

They claimed they abided with the letter of FDA law. But the spirit? The ADHD experts I spoke with two years ago were aghast that these poor Concerta imitations were even approved.  FDA scientists have long pointed out the lack of bioequivalence with novel-delivery system drugs. (Concerta’s OROS is a novel delivery system.)

What about the pharmacists?  Could working for a drugstore chain present a conflict-of-interest? Generics are typically much more profitable than the brand and, in some cases, the authorized generic. When  pharmacists assure customers that generics are “the same as brand,” where does their allegiance lie? Are they compromised—or ignorant? Or both?

Before getting to the first-person accounts from Concerta-generics consumers, let’s quickly review two issues following the downgrading:

1. Mallinckrodt Responds, Sues the FDA

We could anticipate that two downgraded-generics manufacturers would fight the FDA actions.

Kudco has remained mum. But Ireland-based Mallinckrodt, which reportedly saw shares fall almost 7% on the news, responded to the FDA decision by filing a lawsuit against the FDA.

President and CEO Mark Trudeau said this in a company press release:

We believe that the FDA’s actions are not supported by sound scientific evidence and not consistent with the best interests of patients….

…Mallinckrodt methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA, and in the 21 months since launch more than 88 million doses of these products have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug (Concerta) to the company’s methylphenidate ER products.

That 88-million-dose figure raises an important question. Of all the people dispensed this generic, how many actually knew that they were receiving a product inferior to the brand Concerta? A tiny fraction, perhaps. And most of them seemed to learn it from my blog!  How crazy is that?  They also found Kansas-based pediatrician Kristen Stuppy’s blog.

If consumers thought to question their pills’ different appearance, pharmacists often head-patted with “exactly the same!” Many prescribing physicians also had no clue. Incredibly, many still don’t.

Then there’s the “wild card” of ADHD’s changing nature. That is, symptoms vary depending on life changes (a new teacher, a new job, an illness, hormonal fluctuations, etc.). As a result, many  never suspect the medication they’ve been taking for a while, to good effect, has suddenly gone haywire. As a result, they blame themselves—their diet, their stress, etc..

2. FDA Re-Evaluating Generic Standards

My first investigation into this unfolding story took place more than a year ago. I didn’t understand how these two companies could legally foist two inferior generics on a vulnerable public. So, I called a pharmaceutical patent attorney.

The conversation went like this:

Gina: Are these generic manufacturers acting legally? They don’t have the OROS technology. Yet, that’s what distinguishes Concerta from other methylphenidate products (Ritalin, Ritalin LA, etc.). The manufacturers haven’t demonstrated that the medication has the same drug-release profile as Concerta. So how can they claim bioequivalence?”

Pharmaceutical patent attorney: Yes, the companies have acted legally. In fact, what they’ve done is brilliant.

Gina [noting his utter lack of curiosity about the horrifying reports I was fielding from readers]: If you consider sociopathy brilliant.

He had no response.

This Concerta-generics case, coming a few years after a similar problem with a Wellbutrin generic, seems to have galvanized the FDA’s attention. It is currently shifting its stance on generics as always “bioequivalent.”

Note: This was before the 2017 change in the White House. That brought a trampling over FDA scientists’ concerns. We are stuck with these crappy generics for now—but Concerta manufacturer Janssen has introduced a Concerta savings program.

Now! Generic Concerta-Users Stories

Here are stories of real-life experiences with these inferior generics. This is a curated compilation of reader comments to my various blog posts on this topic over the past two years.

These stories are organized into subgroups:

1. Adults who disclosed their profession

2. Other adults

3. Parents of children with ADHD

Thanks to all for your comments. Plus, again, a huge thank-you to those who completed the FDA MedWatch form. I am proud to have opened the MedWatch case.  Yet, without consumers following through, it would have meant nothing.

From a Mental-Health professional:

Dear Gina, 
I’ve worked in the mental health profession for nearly the past 8 years in positions ranging from crisis intervention counselor, to inpatient psychiatric social worker in addition to internal employee assistance counselor. Kristen, and Gina, I cannot thank you enough for all the information and comments in regards to the Kremers Urban manufactured generic of Concerta.

My struggle with treating ADHD did not begin until I was an adult, and over the past 7 years or so I’ve taken the brand version of Concerta with much success.  So much success, that it made the difference in being a C-B student as an undergraduate, to completing graduate school with a 3.54 GPA in 2.5 years, and a plethora of job opportunities post-graduation.

However, over the past couple of months I’ve had problems with impulsiveness, restlessness, short-term recall, procrastinating, lack of interest in learning new difficult subjects, and sustaining attention on familiar topics and conversation of interest, all problems I never had while on the brand for 7 years.

I had chalked much of my problems up to the fact that maybe I was experiencing some adjustment issues manifesting as increased depression and anxiety after a recent move from Southern California to the Midwest.  However in all my years of behavioral health, I felt like I knew better and it had to be something deeper as I didn’t feel as focused as I was in the past. Even on good days while taking the Kremers Urban generic, I still feel like I’m experiencing that “zombie like state” so many have reported from Ritalin, so I started to think this can’t be me and it had to be the medication dosage.

My new doctor labeled me as seeking a “performance enhancement” and cut me off.

After finally bringing up the issues to my new doctor (who I’ve only seen 4x), that maybe I had developed a tolerance for the medication and needed a higher dosage, he quickly labeled me as seeking a performance enhancement and cut me off to recommend we give it another month.

That “additional month” included two holidays, in addition to a 9 day vacation so all in all, it was hard for me to report back to him any continued difficulty I was experiencing. With the same script and dosage in hand, I was off to the pharmacy last week only to find they couldn’t fill my prescription because of a shortage of the generic methylphenidate ER, which prompted me to do some research on why.

Rather than accept an unwanted fate and spend another month struggling or attempting to journal about what’s not working, I’ll finally be back on an OROS starting tomorrow largely thanks to all the information I’ve found through your blog.

I can’t thank all of you enough for the work you’ve done up to this point, it feels so refreshing to know things will be a little easier again beginning tomorrow!

From a Surgeon:

I feel like such the fool, as it has taken me almost 9 months to figure this out. By all appearances, I should have been at the first wave of complaints. I am a physician, indeed a sub-specialty trained surgeon with a practice based upon tertiary-referral complexity level cases.

When I was first involuntarily switched to the Mallinckrodt generic, I thought I must call my prescribing physician to ask if any others had reported the remarkably irregular and apparently unpredictably “spastic” nature of the delivery of the drug! Soon this was overshadowed by a host of other complaints, of which I am hesitant to disclose, lest you think (as I thought) that I had turned into one of those “crocks” that simply reported YES to every possible symptom. (“Crock” as crazy patient with host of unreasonable and illogically connected complaints.)

One thing led to another until by the grace of God I was finally compelled to see the prescribing physician, who casually reported the common knowledge of the poor quality and irregular delivery system of this “bio-equivalent”. I was still relatively suspicious of my “crock”-ness, but was happy to return to the previously steadily effective drug delivery that had offered me such steady support of function over many years.

The result is almost beyond description. As a physician-scientist, I know about the placebo effect. That said, the change in me has been dramatic, and this change occurred in TWO DAYS/doses!

Prior, on the generic, I could not even remember feeling good and was beyond weary of not only my litany of complaints but also of even ME. It was less than 2 weeks ago that I was writing my last will and testament, feeling that if my life was this and this only, it should end. NOW I AM BACK!

“Praying that I could Avoid Harming the  Patient in the Process”

Over the past months, a challenging surgical case, which previously would have given me great joy in solving and overcoming its complex obstacles, became a series of searingly painful tortures I endured, praying that I could avoid harming the patient in the process.

After changing back to the brand on Wednesday, by today (Friday) I did a 6-hour grueling, complex, frustrating, and JOYFUL case. I did not regret being ME as I did it. Nor did I feel as if anyone who endured ME in the process deserved an eternal crown of glory previously reserved for the martyrs. I am back!

I regret my absence, and regret the pain I know my presence has inflicted on others while I was fighting to return.

From a Grad Student:

I am a grad student, and have been on Concerta for a very long time.

After trying many different brands and doses, somewhere around 5th or 6th grade I was started on two 54mg Concerta capsules every day. This worked significantly better than other brands and doses. I have been on the exact same dosage since then (~12-13 years).

A few years ago I switched to the generic. It looked the same and I didn’t really notice a difference [Gina adds: The authorized generic is the same as brand, which is why this grad student saw they looked the same.] I had been warned by my doctor to avoid the generics, because there were various problems with them.

Today, I went to pick up my medicine from the pharmacy as usual. On my way back to campus (I was home for the weekend), I noticed that the pills looked different. At first I was concerned that they might have made a mistake.
I was wondering if anyone had any experience with the Kudco/Kremers-Urban generic Concerta.

Not much of a difference at first, but I feel more jittery than I used to, and I’m finding myself more distracted. (I’m here instead of studying for my last final.) I wouldn’t have minded trying a different manufacturer over the break, but a trial by fire in the middle of finals was not something I wanted.

From a Teacher:

The same thing happened to me! I was concerned [about switching to a generic] but decided to see what happened if I took this generic instead. What happened?  A marked increase in my impulsivity and my tolerance for stimulation lowered dramatically.

I am a teacher and it really started to cause problems for me, especially in the afternoon. It seemed to wear off more quickly.

My doctor was no help. She simply wrote, “time released” on the script, and the pharmacies told me all the generics were time released. I explained yes but not in the same way as Concerta. They weren’t interested and acted like their hands were tied; they have to prescribe whatever is sent by corporate.

I did find a local pharmacy that still has Alza [Gina notes: Alza owns OROS technology that is central to Concerta; the name is printed on brand/authorized generic pills] and switched there. But they too said that they aren’t sure how long they will keep this type of generic.

One thing I started to do was to wait until lunch to take my medicine. This allowed the medicine to start kicking in during the most stressful part of my day. Good luck with this very frustrating change!

From Various Adults:

1. “It is like a caffeine high falling off a cliff.”

It is definitely not the same as the Concerta with the OROS release.

Six years I have used Concerta. I was prescribed the new generic and had to go back as well.

It hits you hard all early in the day and makes you jittery, and then you hit a wall and it is like a caffeine high falling off a cliff. I get to 3 or 4 pm and could pass out and nap anywhere. And I am not a napper.

2. “The pharmacists assured me that these generics were completely equivalent.”

A hearty congratulations from a victim of the false Concerta generics (on this post).

I had been using Concerta for over 5 years, usually paying around $200 per month (54 mg tablets), after insurance. When I would complain about the cost, several pharmacists recommended that I try the generic versions made by Mallinckrodt or Kudco/Kremers-Urban. These were much less expensive, but they were not effective for me at all.

On two separate occasions, I was stuck with a month’s supply of an almost useless drug. Yet the pharmacists would assure me that these generics were completely equivalent to the “real” Concerta.

3. “I am unfocused after 3 hours.”

I just picked up mine yesterday. They are pink and look totally different than the [authorized] generic version, which used to look exactly like the brand name ones.

At first I did some research and found out that this is NOT the same company behind the original generic Concerta [Watson/Actavis], which I have used and had no problems with.

This new version is NOT the same drug. It is crushable and does not have the same delivery system. I am prescribed two 36mgs in the morning, which normally would last all day or 7 hours max. Not now. I am unfocused after 3 hours and feel as if I am taking an IR form of Ritalin now, which is fact it basically is.

4. “This is the best news!”

This is the best news! Like many others, I stumbled across this website when I received my Concerta rx in the Spring that didn’t look like Concerta. It turned out to be manufactured by Mallinckrodt, and I subsequently filed a complaint with the FDA.

I’ve been on Concerta for 11+ years and it is the best drug therapeutically for me. But no matter what insurance company I’ve had over the years, this drug has caused numerous “headaches” —when it comes to cost, generic issues, or what have you.

It is so nice to feel like we finally got a win.

5. “Don’t be afraid to tell your doctor.”

I had to go back to my doctor and get at new script and junk the rest of the Kremers Urban medicine.

Kremers Urban should not be allowed to qualify as a substitute for Concerta.

The difference in effect is compelling enough to make me question how this drug made it through testing as a qualifying substitute for Concerta.

Don’t be afraid to tell your doctor. I was able to get my usual script and was able to work with my insurance to minimize the cost of the brand name I replaced the Kremers Urban garbage with.

From Parents:

1. “He is having problems with black spots in his vision, dizziness, headaches.”

So glad to have found all of these experiences. My son is 13 with ADHD. When we picked up the generic Concerta a few days ago, he noticed that it looked different from the previous generic.

I checked the bottle and decided that they must have switched manufacturers but told him to go ahead and take it.

With the Kremers pill, he is having problems with black spots in his vision, dizziness, headaches, & numbness in his fingers. Thankfully, our doctor is great and told us to discontinue for a few days to ensure the reaction goes away and can for sure be linked to the Kremers generic.

After that, she will make sure that we only get the brand name and will write the insurance if needed. It’s amazing to me that pharmaceutical companies can get away with subpar work such as this.

2. “For 4 straight days had a dizzy-headache effect at the 4-hour mark.”

My son has also been on a dosage of two 36mg Concerta tablets daily for more than a decade without incident.

In December, he got the Kremers Urban generic. For 4 straight days had a dizzy-headache effect at the 4-hour mark. He stopped taking the drug, returned to the pharmacy, notified his doctor, and reported the adverse effect to Kremers Urban and to the FDA.

It is only through reporting these issues to the FDA that a database on the issue can be maintained and the manufacturer is forced to dig deeper into the performance of his product. My son has returned to using only Concerta, which for him ends up being $490/month.

3. “I was not looking for problems.”

I was delighted to get the Mallinckrodt generic because I saved $80 on my co-pay. Then I tried it.

I was not looking for problems, but noticed a day in that the drug was not working as the Alza version did. Now I am working to get my pharmacist to switch his generics to the Watson version.

4. “We did not experience any of these problems with the Concerta.”

Four days ago, my pharmacy gave me a generic (Mallinckrodt ER 27mg) instead of Concerta for my 11 year old. It does not seem to be working, or working inconsistently. My child has become very forgetful, difficult to deal with and is unable to fall asleep at night. We did not experience any of these problems with the Concerta.

5.  “It’s so hard to know if this is a blip in his treatment, if he needs a higher dosage or if it has to do with the generic.”

My 8 year old was on Concerta 18 mg for one month for ADHD. For the second month, the pharmacy gave me the generic and assured me I would see no difference.

Day 3 and 4 of the generic meds (after the weekend) and he’s having issues in school. Not getting along with friends, crying over spilled water, not having as much self-control, etc. It’s so hard to know if this is a blip in his treatment, if he needs a higher dosage or if it has to do with the generic.

6. “Now I need to find another medication. I hate to do that because Concerta works so well for him.”

I had the same problem with my 9-year-old boy. He was on Concerta and we tried the generic. He didn’t like it, said he could tell the difference and it didn’t work as well.

Now his insurance said they won’t cover anything other than the generic. Now I need to find another medication to put him on. I hate to do that because Concerta works so well for him.

7. “My son is 7 and started hurting himself.”

My son is 7 and was given the Kremers Urban generic Concerta. He started hurting himself.

His doctor and pharmacist agree it could be something in the medicine, a preservative he’s sensitive to. His therapist doesn’t understand how this generic Concerta is being seen as time release without the [OROS] capsule and that also may have played a factor. He’s getting too much at one time.

I am ANGRY at my pharmacy because it is their job to know these things.

8. “My son told me to PLEASE find the old medication.”

My son is 7th grade, gifted, A-student who has been doing well on Concerta brand and also the Watson [authorized] generic.

Last month our pharmacy switched to the Mallinckrodt manufactured brand and everything changed. His impulse control and focus issues were back with a vengeance. He noticed a marked difference in the effects of the medication throughout the day, and he told me to PLEASE find the old medication.

I’ve done some other research and according to the press release for the Mallinckrodt product, “the FDA found that our long-acting technology delivers a dose which is therapeutically equivalent to what is currently on the market.” I disagree completely with their statement.

9. “I am having a hard time finding Concerta brand or the authorized generic.”

I am having a hard time finding Concerta brand or the [authorized] generic from Watson. All I can get is the pink generic. My question to the pharmacy was “If its pink does it have red dye 40? Many children have issues with that” [Yes, very possibly some people will react to the dyes and fillers in the generics, which are often different than in the brand. I touched upon that in this post.)

10. “The doctor wrote, ‘do not substitute’ and we still received the generic.”

I specifically request Watson and they told me it has not been available. I also had the doctor go back to “do not substitute” and still received the generic (which I sent back). I had to go to a different state to find the brand because not one pharmacy had it. This is getting ridiculous. With our plan, I can only to go CVS or Rite-Aid.

11. “He gets very depressed and says that he is stupid cause he can’t concentrate…”

My 9 year old son had been on Concerta for the last 2 school years. This year he started out fine in October but November he started acting weird: He was always scared, even in the day time’ he wouldn’t be in a room by himself and was always hearing things and seeing things.

His pediatrician told me to take him off the medication for the holidays. That made a world of difference. He is still afraid to sleep alone. But he is functioning like a normal 9 year old.

He is now on Intuniv. All it does is make him tired. He has only been on it for 3 days so I’m hoping it will eventually work for him. He has been home sick this week and when I’m helping him with makeup work.

He gets very depressed and says that he is stupid cause he can’t concentrate…

12. “He was asked to leave the school in November.”

My 9 year old has been on Concerta for several years. We switched him to generic Concerta in June, and I didn’t notice any change. Looking back now, I think this is because he was out of school and his days were just composed of fun activities and free time and he didn’t really have a lot of opportunities to get frustrated over work.

When school started, we put him in a private school that specializes in kids with learning differences. At first we thought he was just taking a while to adjust to a new school, but his behaviors only increased in severity. He refused to do any work, would run out of the classroom, screaming/crying/fits, and eventually started attacking the other kids. He was asked to leave the school in November.

I home schooled him for a month while I worked with our local elementary school to get his services back in place. He has been in this school since he was 3 and we’ve had a great team of aides and support people.

Right before Christmas, he started going to school for just half of the day. We all agreed that since his behaviors had been so much more intense than they were in the past, that a half-day was probably all he could manage. The team at the school has been documenting every outburst/whine/tantrum and keeping a detailed spreadsheet. We have probably 4-5 weeks worth of sheets now and every day (four hours) he has an average of about 10-12 behaviors that require the team’s attention. He spends a lot of time by himself in the resource room, by choice.

Last week, a friend gave me her son’s leftover name-brand Concerta that he was not going to take. It was the same dosage as normal for my son. (Yes, I know this is probably frowned upon, but we do what we can to save money.)

He took the first one on Saturday. On Monday and again today (Tuesday) at school, he stayed in the regular classroom the entire time and did not have a SINGLE issue. This is a child who at times has three adults with him at school to help manage his behaviors and he made it through two days without a single whine, cry, anything.

His team was amazed and asked about any changes in his routine. The ONLY thing different has been the name-brand Concerta. But after having every day at school be a disaster since August, getting kicked out of a school that specializes in helping kids like him, and reducing the length of his school day by 50%, this is truly miraculous for him.

13. “Her behavior had turned defiant again, like before she started taking Concerta.”

My 8-year-old daughter’s teacher informed me that her behavior had turned defiant again, like before she started taking Concerta. She wanted to know if she had been forgetting to take it. After looking into it, I realized the last refill had been generic.

I found out that, yes, the medicine may be the same in Concerta and the generic. But the capsule is made differently, which causes different delivery amounts and times. Something as small as this made a big difference in my daughter’s behavior.

13. “Holy cow, it was night and day difference for my child.”

Wow, I can’t tell you how thankful I am to come have come across this website. My son has been on Concerta 27 for a little over a year with great results. He has received a generic for each fill, but it had always been “the good one” until this last refill.

Holy cow, it was night and day difference for my child. There have been more tears, emotional outbursts and general unhappiness than we’ve had since before he was diagnosed. This holiday break has been miserable for our whole family.

I finally called his doctor this morning.  She just scratched her head and couldn’t figure out what could be different. Maybe it was just the stress of the holidays, she said.

But one of her nurses did some research and came across your information. She called every pharmacy in our area until she found one that carried the authorized generic. Then she got us a new script.

Thank you for getting this info out there. I’m so angry that this drug company messed with people in this way.

14. “My pharmacist had to circumvent his company’s standard procedures”

My pharmacist told me he had to circumvent the standard procedures of his company (a large supermarket chain), in order to get the Actavis product for me instead of the other “generics.”

With this new victory, it should be much easier for conscientious pharmacists everywhere to order the “authorized” generic. Congratulations again, and thanks for all your good work.

15. “I’m about to pull my hair out. If it wasn’t for your website I would have still been confused.”

Recently my normal pharmacies were out of authorized-generic Concerta. So CVS had some of the other generics.

Three days later, I’m about to pull my hair out with my daughter’s behavior. The pills they sold me are the Kremers Urban!

If it wasn’t for your website I would have still been confused. I think the ones in charge should get a dose of meds that produce the same horrible effect it has had in my daughter!

16. “Through your blog, I [saved $193/month].”

Through your blog, I learned about the Actavis “authorized” generic. By presenting your detailed comparisons to him, I got my physician to specifically prescribe the Acatvis product.  [UPDATE: PLEASE NOTE that Actavis is no longer the distributor of Concerta’s authorized generic. That’s the brand sold as a generic.  The authorized generic is now available from Patriot Pharmaceuticals,  a subsidiary of Janssen (Concerta’s manufacturer).]

When my first script was filled this past March, I stood literally slack-jawed with surprise at the pharmacy counter: the cost was $7! That is NOT a typo: I mean $7—for the very same drug that I had been paying about $200/mo.

Please share your opinions or first-hand experiences regarding these Concerta generics—or other ADHD-related generics you or your child might be taking. 

—Gina Pera



20 thoughts on “Sound Off: Users of Downgraded Concerta Generics”

  1. Thanks for posting this. Like the comment below, I was switched to Trigen. I’ve been on Concerta for well over a decade, alza stamped pills for the majority of that time, but various generics during the past couple years. Trigen is an obvious imposter, as it comes in a circle form instead of the regular oblong style.

    I have had strange heartburn/stomach issues for a couple months now, and after ruling out many other things, I’ve finally connected the symptoms to starting within weeks after I was switched to the Trigen mft generic.

    Lowering the dosage has improved my side effect symptoms and tomorrow I’m going to a new pharmacy that has assured me they can order the authorized generic.

    Trigen should be banned…

    1. Hi Josh,

      I’m glad you made the discovery — and found the pharmacy that can help.

      IMHO, ALL these “Big Generic” companies that exploited FDA loopholes should be banned — and sued.

      As you might have read elsewhere on my blog, when the first three generics came out (with similar effect), I called the FDA to see what was happening. i was advised to open a MedwAtch complaint. Readers followed my suggestion to register their complaints. It wasn’t long before the FDA declared these generics “non-bioequivalent.”

      But then 2017 happened and the White House appointed an FDA chief who overrode FDA scientist concerns, pushed through dozens of generics, and then went back to the rightwing think tank from which he had come.

      The public largely has no clue.


  2. My horror story is about the Trigen Laboratories version of Concerta 36 mg. Onset not for 3 to 4 hours, then from 6 to 11 hours after dose, experienced horrorible mania, muscle tension, BP to 144/88(was 110/70 on approved generic). Thought I was going to die! This brand should be banned by FDA or have a black box warning!

    1. Hi Nancy,

      I’m sorry you didn’t find my blog earlier. I’ve warned about this for a few years now.

      You are welcome to file a complaint with the FDA.

      A few years ago, we succeeded in lobbying the FDA to downgrade first two generics.

      With a change of White House administration in 2017, a boatload of Concerta generics were approved.

      That ship has sailed, I’m afraid.

      Elections have consequences. 🙂


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  5. Thanks for this info. My regular doctor was out of town, so one of her associates wrote my prescription. The pharmacy said they had not specified “no generic” so gave me Methylphenidate instead of Concerta. Boy, I felt like a steam engine riding the rails, taking curves at unsafe speeds, and not caring at all. I even texted my ADD Support group that I felt I had no filters…No brake pedal, couldn’t stop talking, sharing on Facebook, etc. Glad to know I wasn’t going (more) crazy. I felt a little dangerous while under the influence of this generic drug. I sure hope no one has been injured as a result of switching meds. It is not right that we are given this med without proper warning.

    1. I agree, Ginny; it’s not right that people were given this medication without proper warning — and that some even had pharmacists “gaslight” them (that is, tell them that the inferior generics and brand were exactly the same).

      I’m glad you were not hurt.

      I’m also glad that, in the surgeon’s story, no patients were hurt!

      But we don’t know about all the stories that didn’t make it to my blog. 🙁


  6. WOW after reading everyone’s current comments about the recent issues surrounding generic versions of the Name Brand Concerta I’m starting to feel “abnormal”. I’m an older adult having gone through many years of misdiagnosis then 6 years ago being correctly diagnosed & treated for ADD. As typical my therapist & I tried a variety of medications & doses to find what seemed to work best.
    Maybe it’s because I have employer provided medication insurance that I’ve always only been prescribed Concerta “generic”. It’s always been a little white pill. I took 3 -36mg each AM, to last all day since it was ER extended release. Then late in 2014 I started having difficulty with getting prescriptions filled and would have to try different locations & pharmacies. CVS is the first to have given me “generic Concerta” that wasn’t the little white pill I was used to – but rather it was a little orange-pink pill. I questioned them about it and they showed me the writing on their master bottle and it did state it as being methylphenidate ER. This all seemed OK since I’m familiar with name brands having various generic versions that appear different depending on manufacturer. This continued for several months – sometimes my prescription was filled with white pills, other times orange-pink pills.
    My job keeps me very busy at my office as well as traveling all over the state regularly. I have a hectic schedule and rarely seem to catch up, but then that’s part of being ADD. It took several months for me to start noticing a difference. I decided it was just all “in my head”. I hesitated to mention anything to my therapist after all “generics are the equivalent and should have no differences”.
    Around the same time, Nov 2014, I did some web research and ran across your site as well as the newly released FDA notice about the Concerta generic issue. After working hard to select the correct words to describe the differences I felt, I shared this and the FDA information with my therapist.
    However, and this brings me back to feeling “abnormal” after reading your recent posted comments – I was telling my therapist that I preferred the effects from taking the orange-pink pill (Kudco/Kremer Urban)l rather than the white one (Alza, the authorized generic)….. and for virtually the exact opposite reasons mentioned in most of your posts. In comparison to the orange-pink pill, the white pill produced increased impulsivity, distractibility, “time in my head”, and need for extra stimulation. With the orange-pink pill I could better handle overwhelming situations, multi-tasking and need for sudden shift in attention. I had determined however that of my 3 – 36mg pill, I needed to only take 2 in the AM and the 3rd around 1:00PM.
    My therapist is OK with me taking the orange-pink pill but now we have the bigger problem of trying to get a prescription written in the wording pharmacies will accept. My therapist no longer writes Concerta generic. He now writes “methylphenidate ER (Kudco/Kremer Urban Mfg) specific generic” but the last 2 times, pharmacies have filled it with Alza. Finally this month I got the orange-pink pill (Kremer). I’ve been on it 4 days now AND YES – it’s not in my head – I do notice and prefer the difference in effects. This just all goes toward emphasizing the complexities within each individual’s set of ADD traits & characteristics…. and the difficulty each therapist has in order to appropriatly help each individual ADD patient. Thanks to them all for trying and not giving up on us!

    1. Hi Diane,

      Good for you, for listening to your instincts.

      I tried to emphasize, in my reporting on this topic, that for some people these generics might actually work better than the brand. But I probably didn’t emphasize it enough>

      It’s not that these generics are “bad” medications; it’s just that they aren’t close enough to Concerta to be called Concerta generics.

      As you found, the Kudco is actually a better fit for you, and that doesn’t make you “abnormal.”

      One of the first slides I use in all my presentations is that of a cookie-cutter, to emphasize that people with ADHD are individuals. We are lucky today in that we have an array of stimulant medications, in an array of delivery systems. That means each individual has a greater chance of finding the best fit.

      I’m not sure what Kudco is going to do with its product — perhaps market it under another name. If you have trouble finding it, you might want to try Ritalin LA. From what I understand, it’s very similar to these generics.


  7. After having issues with so-called generics, I was very grateful when I found your earlier article on the subject and have gone out of my way to find Watson Labs version of Concerta ever since. One by one almost all the pharmacies in the Santa Barbara area have stopped carrying the Watson Labs version because they say they lose money on it. There are only major chain pharmacies in Carpinteria (my town, between Santa Barbara and Ventura), which can’t go against parent company policy. I was going some distance to the clinic pharmacy, till they, too, discontinued the Watson Labs version a couple of months ago, sending me scrambling to find the last remaining supplier in S.B., a locally owned independent compounding pharmacy (at least they used to be). It isn’t convenient to go there every month–they have no parking lot, they’re on a busy street and have shorter hours than the chains–but it could be much worse. The state doesn’t make it easy, either, requiring a new prescription every month that has to be delivered in person, meaning one also has to wait around for it to be filled or come back another time, but there’s nothing that can be done about that at present. Should this Pharmacy decide to go the way of others, I’m not sure what I’ll do.

    1. You might have to drive even further, Meredith, to LA. Or check into your mail-order pharmacy benefit.

      Good luck,

  8. Edward Shannon

    Hi Gina, Thank you again for your response. All people using this drug need to be aware of this situation. As long as one person is still being deceived and believing this is a true (absolute) generic of concerta I don’t believe the FDA or the pharmacies still dispensing this drug as a generic of patented Concerta are acting responsibly or honestly. With all of your hard work in exposing this inferior “sociopathy brilliant” non-“bioequivalent” and noneffective product as generic to Concerta, innocent victims are still suffering because they are ignorant of this truth and it is still being sold to them. I thank you again Gina for helping people to know the truth. Edward

    1. Thanks, Edward. You are absolutely right, and thank you for seeing my goal: Educated consumers.

      It sure seems that the pharmacies should be required to tell consumers of this problem before filling their Rx.

      Overall, I must say, I’m very disappointed in what seems to be the profit motive overriding the pharmacist-patient relationship.

      take care,

  9. Gina, I have far more than 68 patients in my practice that have been harmed by the down-graded generics. Harms range from shorter duration of treatment to some serious side effects–anxiety, mood irritability. Few have the time to write Mallinckrodt with a detailed account, and I don’t have a way to track and report the problems accurately.

    What I do know is that my staff and I spend hours helping people understand the issue and finding qualified generics.

    Thanks so much for your work championing this issue. It matters.

    1. Thanks, Oren!

      I’m so happy if my tedious work is actually helping real people!

      Thanks for letting me know.

  10. Edward Shannon

    Thank you and everyone else concerned Gina. I have been a long time user of concerta until a year ago when I suspected something was not right. But what can a person do in these situations The last year has been a nightmare,switching to adderal without getting desired effect and losing my will to keep going. I did discover Nuvigil, and very satisfied with results, which I cannot explain in words other than it makes me feel weightless and not having the feeling of not having enough energy to move, along with losing that feeling of being too tired to do. The Doctors don’t know what to say, and the pharmacist treats you like you are an addict lying to get more drugs and the press wants to turn us into criminals. What these drug manufactures are doing is not right and it is criminal what they are doing to us. They didn’t just make a little error of quantities, they are robbing us and getting away with it. If anyone takes action (Classactionlawsuit) all they do is dole out the money to the lawyers, the lawyers contact a few of the injured$25. and who knows where the millions end up. They settle out of court, never admit to anything and never even go to jail, and people believe that all it was was a mistake.It keeps happening over and over and over. the same way and same companies. I have received

    I believe it is about time people start using their brains and realise what big business and governmet doing to us. They are lying and stealing from us and it is intentional. CVS sold my son 90 days worth of bogus 36s, on December 28,2014 when, from what I understand, the FDA banned them from sales, but then what happens, the FDA allows them to continue selling the bogus drugs to us, they sell off their bogus inventory clean up their act and it is all for gotten. Just look at all the money they just got away with stealing from all of us and violating our rights by denying us our right to be decent and normal by giving us something we did not ask for. I paid CVS $898.72 for a three month supply of IC Methylphenedate ER 54 Mg Tabs that was “for Concerta”, I asked them politely if they had heard anyone say it “wasn’t doing” what it always use to do”. I asked them if there was any way to check its content. On and on and on. They continued selling the same stuff to me while treating me like an addict. Whatever CVS knew I don’t care, I care about what Kremers Urban knew and did. How can or why should we live in a world where corruption rules.

    1. Hi Edward,

      I really appreciate and sympathize with your situation, and that of everyone affected by these inferior generics.

      I would just point out a few things, though:

      1. Some people actually LIKE the downgraded generics. There is no safety issue per se. And, for some people — individuals being what they are — the delivery rate of the downgraded generics works better for them. So, that’s why these medications are still available.

      2. What the FDA downgrading did was ensure that pharmacies could not automatically substitute a prescription for Concerta with these inferior generics. That’s a win for consumers. But as with anything, consumers have to watch where they shop and look out for their interests.

      3. This action has actually shown that “big government” represents the interests of the people, in my opinion. When I called the FDA almost two years ago, I had little confidence that I would be able to remedy this situation; I anticipated that the bureaucracy would swallow my concerns and spit them out. But I felt I had to try.

      When I finally found someone willing to talk with me, someone in a fairly high position, I was impressed with this FDA official’s genuine concern for what I was reporting. Many people, including scientists, working for the FDA do so out of public interest, a desire to serve; many could be working for much more money in private industry. I’m sure a good many of them have long had concerns about “generic bioequivalence” but their concerns have been outshouted, perhaps by “little pharma’s” industry lobby in Washington.

      So, I think this turn of events is truly heartening, and another reason to demand accountability from our government instead of throwing up our hands and saying, “they’re all crooks.” We get the kind of government we deserve, I believe, and I’m really impressed with the FDA’s actions.


  11. Masked ADDer

    Boy, the notion that the generics are more profitable to pharmacists than brand names is a whole new perspective to me, and many people as well, I suspect. This matter requires very serious consideration of potential conflict of interest. Unfortunately, large-scale prescription data are only available from a private source, such that potential conflicts will remain hidden, sigh… Thx Gina for an amazing post!

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