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Generic Adderall Recall: Oversized Barr Dextroamphetamine/Amphetamine

The FDA and Barr Laboratories, Inc. have announced a recall for generic Adderall tablets that may contain more of the active pharmaceutical ingredients than they are supposed to have, posing a risk of serious side effects among users of the ADHD drug.

The generic drug recall was issued on August 14 for one lot of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (mixed amphetamine salts) 20 mg tablets, which were sold in 100 count bottles. Some of the tablets from lot 311756 could contain tablets exceed weight requirements, which may result in super-potent pills.

The generic Adderall tablets are approved to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy, and are also often used off-label for weight loss. The 20mg pills are oval and peach in color, with “b/973″ stamped on one side and “2/0” stamped on the other. The recalled Barr ADHD pills were distributed between June 11, 2009 and June 16, 2009, but could have been filled by a pharmacy after that.

Taking an oversized pill could lead to an overdose, with symptoms like palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth and decreased appetite.

No injuries have been reported in connection with the oversized tablets, according to Barr Laboratories. Consumers who have any of the recalled dextroamphetamine/amphetamine tablets have been advised to stop using the drug and contact their doctor or pharmacist. Any adverse reactions should be reported to the FDA’s MedWatch program.

The recall is the latest in a string of recalls involving generic drugs that were distributed with too much of the active medication in each tablet.

In late June 2009, U.S. Marshals raided generic drug manufacturer Caraco Pharmaceutical Laboratories, Ltd., shutting down production due to unsafe manufacturing processes that allowed similar problems to occur. In March, Caraco issued a generic digoxin recall for tablets of their heart medication due to irregular sized pills.

In April 2008, a Digitek recall was issued by Actavis Totowa for their brand of digoxin which were distributed with up to twice the appropriate amount of the active pharmaceutical ingredient. At least 667 deaths from digoxin overdose were linked to the recalled Digitek tablets in FDA adverse event reports following the announcement of the manufacturing problems.

Last year, generic drug maker Ethex Corp suspended manufacturing and shipments for all products after issuing several generic drug recalls due to oversized tablets. Among tablets that were distributed with too much of the active medication were generic versions of morphine, which could cause a potentially fatal morphine overdose. Also included in the recall were dextroamphetamine tablets that were generic versions of Dexedrine and Dextrostate.

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117 comments

  1. Jahulobo Reply

    I have been using Barr (now Teva bought Barr out), for years. I had EXCELLENT results for years and years on Barr brand UNTIL around three years ago. I am no longer myself anymore, but just trying to function with the pieces that are left of me as I feel I HAVE to take something!! Sandoz/Eon Labs seem to be in hiding or maybe they don’t ship to may pharmacies in the USA, well at least not anywhere near Greenville, SC. IF ANYONE could lead me in the right direction, I would be etternally grateful! I can use my discount card at BILO, WAL-MART, K-MART. Some othe places like CVS, WALGREENS, RITE-AID aere still autrageously expensive even for the gernerics. Let me ask you all this question– I taked Barr/Teva brand Adderall IR. Is the Original Shire formula the same and as effective as it has always been? Thanks so much!

  2. John Reply

    I don’t know if I received “higher dosage ” dextroamphetamine or not but I can tell you that taking this drug has ABSOLUTELY ruined my life. I lost my family, quit jobs impulsively, lost tons of weight, picked at head until scabs formed, ruined myself financially financially through impulsive gambling, started smoking, stopped sleeping ETC., ETC.
    Immediately after I stopped taking Dextroamphetamine, all these behaviors stopped for me…..I can’t believe I smoked(have never had the urge since), can’t stomach the fact of losing one cent to a casino (haven’t gambled since), am back up to my normal weight (because I actually have an appetite)………but you know what……it’s all too late because my life has been destroyed by this drug AND I’M REALLY PISSED OFF !!!!!!!!!!!!!!!!!!!!!!!!

  3. Clint Reply

    Getting on this drug has been the worst mistake of my life. I am a 52 year old married guy who has been on this drug for about the last seven years. The previous years of my adult life were productive and enjoyable, now days I just seem to exist like a caged animal. I have quit the drugs for months at a time, but gained lots of weight and struggled to even get off the couch. Prior to going on this drug I had launched and managed three businesses, personally built three houses and ran a youth sports league with 2000 kids. I have experienced just about every side effect mentioned; high blood pressure, skin rashes, severe constipation, teeth grinding, obsessive behaviors, racing heart, but yet I can’t quit. I can’t believe the drug industry, medical industry and our government would condone this drug considering what I have learned about it over the last few years. Especially considering Shire bought the formulation which was originally marketed as Obetrol, a weight loss drug in the 60’s and 70’s that was apparently taken off the market because too many women were addicted to it, relabeled it and marketed it to kids in the 90’s!

  4. Ms. Rogers Reply

    I’ve recently been permanently disabled due to severe unknown cardiac conditions… well, a few are known of, but my condition is nothing any cardiologist in Boise Idaho has ever seen let alone a St. Judes Representative. I was born with SVT that presented itself in 1999, age 19. After undergoing 2 heart surgeries, a pacemaker and numerous tests, I am now disabled. I have a new baby on top of all of this. In 2009, I was taking the 20mg Barr Brand Adderall. I had severe complications during the months of June, July and in August was told the SVT had returned, over riding my dual chamber, top ventricular pacing pacemaker. I was placed on Heart Failure Medication. Do I believe the Adderall being twice the actual dose per pill had everything to do with my current condition? No. However, as I stated my life took a turn for the worse during that recall as did my health ultimately leading to loss in my career and completely bed ridden by November 2009. I still take the Barr brand Adderall however, I switched to the 30 mg tablets after the 2009 recall. I would suggest others do the same as the Recall has occurred again.

  5. Ms, Jonny Reply

    I also have severe kidney issues not too mention went to see an eye doctor for the first time in my life. I have 20/15 vision yet still need glasses? I lost everything in my life at this time on my life… well at least thats about the time things started going downhill head first. June and July of 2009 was the beginning of my end… I’ve lost everything including myself. It is absolutely concerning to me that marijuana is illegal and wayyyyy tooo many are sitting in prison or jail for such a harmless substance yet these drug companies are allowed to profit billions from us and putting us all in harms way to do it…….. WELCOME TO AMERICA… LAND OF THE FREE RIGHT????

  6. christina Reply

    I have taken adderall for a year now. Mine is the 973/20 orange. I started off with the blue tablet.

    i lost my appetite severely last July,then got really sick to my stomach. After several E.R.visits w/in a week. My gi dr did an endoscopy on me and diagnosed me w/gastroparesis. I had to have a wire in my stomach,up my esophagus and out my mouth. Then I now have an implant. I just started back on the adderall and it caused such severe abdominal pain that I had to stop it.

  7. Anna Reply

    I see this recall was in 2009, for b/973, 2/0.. yet I have the same recalled pills in my 2011 prescription fill in my hand now… What do we do about being sold recalled pills from 2 years ago? My Lawyer is lovin this :( I wish an organization would stand up for us voters that are being heavily medicated by drugs under the law, prescribed to help us, all the while stats show thses prescription drugs arent helping anyone evolve what so ever… they are stunting our growth, creating dependances, and numberous other terrible side effects.

  8. Cotton Reply

    Why is such a big differences between manufactures when it comes to the same medicine..Then when u try to find out what the differences are, u can;

  9. Heather Reply

    this is an outrage. Adderrall is the best drug out there for adhd anybody that has complained about any side effects obviously dosen’t know how to take it correctly, because of everyones over paranoid complaints people like me who need to take it everyday are now stuck without it because they are recalling it all over some stupid made up complaints i’ve been on it since 9th grade i’m 24 years old now and am in perfect health so for all of you that felt the need to complain thanks a lot cuz i’ve been without it for days and can’t find it so screw you all!!!!!

  10. J Reply

    Goes to show that the standard refrain of pharmacists and insurers that there is no difference is an often mistaken generality. Not necessarily bad. My Dr. told me to make sure to go to Rite-Aid or other pharmacy ro get the Barr orange ovals, because his patients getting the other brands from Walgreens complained that they didn’t work. There was something wrong with the others! Heather is right. If you get too much out of the brand you’re taking, take less or ask for a different brand. Don’t turn it in to a basis for suing for profit and make the very useful drug unavailable to those of us who need it and have some common sense. There’s a nationwide shortage now, and the dangers of the basic drug are no different.

  11. Kim Reply

    The people at Barr Pharmaceuticals are liars!!!!!!! I reported to them the serious side effects my daughter was having via email to their web site in August 2009, and I never heard back from them! I also made a copy of that email. I didn’t realize at that time that I was no longer getting the name brand Adderall, and for two months, my daughter and my family went through Hell! We were frightened of her when she suddenly became extremely violent and was severely scratching/pinching/hitting everyone, threatening to kill us with knives, screaming, throwing heavy items and breaking items. She was agitated, restless and also had insomnia. We all have scars on our arms from her scratching us and I also have them on my face. I was looking at putting my daughter in an institution and then I discovered that the pharmacy filled her prescription with the new Barr generic 20mg XR. She NEVER had any of these side effects with the name brand Adderall! I immediately made an appointment with her doctor and applied to have the name brand approved for the insurance. When we stopped the generic Barr Adderall, the side effects immediately stopped!!! My poor child and family suffered because of this horrible drug. Of course, they never let me know that there was a recall and I just found out now. If there is a class action lawsuit, I will happily join in!!!!!!

  12. Laura Reply

    My husband is a OTA and works with Doctors all day, He was told by a Doctor friend of his that “Dr’s just practice medicine, which means they are only about 50% sure of what they are doing”. Same goes for Pharmaceutical companies….WTF?

    And for the past year or so I have been getting terrible headaches, I’m talking light out, don’t move kind of headaches. First it started maybe one every 3 months then once a month and now I had 2 in 10 days? I finally went to my Dr and she said it could be the Generic brand of my medication, I thought they had to have the same active ingredient yes they do but it could be a different % of that ingredient. Oh come on !!!!

  13. Debbie Reply

    September, following 3 months of taking the “super pill”, I have been diagnosed with neuropathy, diabetes, chronic headaches, and high blood pressure. I have been fighting these conditions for 2 years. Prior to the incident my headaches were not as bad and I had perfect blood pressure. I was not able to work from December 09 until August ’11. I am still battling the headaches, diabetes, and high blood pressure.

  14. Jo Reply

    I am another victim. Usually take the Barr 10mg 2x/day. Due to the unavailability of that generic the pharmacy replaced it with the 20mg “Super Pill” that I broke in half every day for a month. I thought I was going crazy. Debilitating headaches and a brain fog that was like nothing I ever experienced before. It made me sick and completely unable to function. I unfortunately did not realize it was this stupid superpill causing my sickness until I took it for a month. I am lucky, I began feeling better within ONE day of dc’ing it. BEWARE OF BIG PHARMA. & WHY is Walmart still allowed to dispense this pill two years later?

  15. Mike Reply

    I took one of the 20mg adds and noticed that it made sex feel sensational! An orgasm lasted at least 2mins, and I felt high. I saved everylast one of those pills and told my pharmacist I flushed them, so I got 120 more for free. The super adds, I save them for when I’m about to get sexual with my GF, and may take one when I really have a lot of paperwork to do, my advice is don’t take the whole pill, even the beads themselves are XR. Split it or third it, no need to take them back, & you mite find them useful in sexual situations…;)

  16. mary Reply

    i was on adderal 10mg xr, then i switched to the generic, 20mg. wasnt xr, i took them for a week and noticed a big change, i wasnt focused, i was tired all the time, and it felt like i was a zombie,, but when i was on adderal xr my whole life changed,, my husband even noticed i was a different person not just cause of the stimulant but because i was more focused and organized. so i went online to see the side effects of the generic and i run into this about the recall,,, my pills have the same stamp on them , could they be from the same lot.

  17. Donna Reply

    On October 31, 2012, I had my prescription for Amphetamine Salt Combo (30mg) tablets filled at Walgreens. I noticed that the new prescription was a different size, shape, and color from my previous prescriptions. When I started taking this new prescription, I began having daily side effects of constant nausea, headaches, nervousness, and irritability. In addition, I noticed that I was not getting the same results for my ADD.
    I spoke to the Walgreens pharmacist and told him of my symptoms associated with the new prescription. He told me that they are receiving the medication from a different manufacturer called Teva/Barr. My previous prescriptions were from CorePharma. Teva Pharmaceutical Company bought out the Barr Pharmaceutical Company in 2008. Therefore, prescriptions labeled with either Teva or Barr are the same and manufactured by the Teva Pharmaceutical Company.
    I called several pharmacies until I located the medication from CorePharma at K-Mart. When I picked up my prescription from K-Mart on 11/29/2012, I told the pharmacist about my side effects and the ineffectiveness associated with the Teva/Barr brand medication. He informed me that I was not the only customer that has expressed the same complaints about the Teva/Barr brand amphetamine tablets.
    I went online and did a search for Teva/Barr amphetamine tablets side effects. I was amazed at how many people have reported the same side effects and/or ineffectiveness of this drug. I started taking the CorePharma brand medication on 11/30/2012 and did not have any side effects. In addition, I am once again experiencing the drug’s effectiveness for my ADD.
    I hope that by reporting the unpleasant side effects and the ineffectiveness of the Amphetamine Salt Combo Tablets manufactured by the Teva/Barr pharmaceutical company will prevent others from having to suffer from the same consequences that I endured for the past month.

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