Here we go again: another generic metoprolol recall from an Indian drug company. The FDA announced problems with Dr. Reddy’s metoprolol succinate 25 mg extended release tablets and the company is in the process of recalling 1,356,000 pills.

What is going on with this heart medicine?

What is Metoprolol?

Toprol-XL (metoprolol) is a beta blocker in the same family as atenolol and propranolol. Tens of millions of people swallow beta blockers every day to control heart rate, reduce the risk of a second heart attack, prevent migraines and ease the pain of angina. These medications may also lower blood pressure.

The original brand name medicine was developed under the name Lopressor and was an immediate release product. That means it had to be taken up to four times daily. That was inconvenient for many people. The extended-release formulation, Toprol-XL, was approved in 1992 and was given once daily, making it far more patient friendly.

Problems With Generic Metoprolol?

We first suspected that there might be problems with generic extended release metoprolol succinate in 2007. Readers of our newspaper column and visitors to our website began reporting therapeutic failures when they were switched from Toprol-XL to metoprolol succinate. Here are just a few of their reports:

“After taking Toprol XL with good results for three years to control cardiac arrhythmias, I was given a generic substitute three weeks ago when I switched pharmacies.

“After taking the daily dosage for five days, I began having more and more arrhythmias to the point of having to be admitted to the hospital. There were no other differences in my daily life.

“After discharge, I returned to the unused brand name drug (Toprol XL) and have had no further problems.” Nancy, March 20, 2007

“I have been taking brand name Toprol XL for quite some time without any problems. Last week, I ran out and my doctor phoned in the refill for a generic prescription. I received metoprolol ER.

“I took it for 7 days. This is absolutely NOT the same. I have a blood pressure cuff that records my last 100 readings. During about the first 12 hours after taking it, my blood pressure was way too low. During about the last 12 hours, my blood pressure was much higher than it ever was. I am on my way now to pick up a new prescription for the brand name, at an additional cost to me, of course.” Debbie, July 5, 2007

On October 21, 2007, we wrote to alert the FDA and its Office of Generic Drugs about the problems patients were reporting with this medication. We were told, in essence, “We’ll get back to you.” We heard nothing more.

A History of Generic Metoprolol Recalls

Over the last several years there have been a number of recalls of generic metoprolol. In 2008 the FDA warned Sandoz that its formulation of metoprolol succinate had not been properly validated. There were dissolution problems. In other words, it didn’t dissolve properly in a test solution. Sandoz recalled its generic formulation of metoprolol that year.

In 2009, Ethex, a subsidiary of KV Pharmaceutical, also got into trouble with its extended-release metoprolol. The company eventually pleaded guilty to felonies of failing to notify the FDA about manufacturing problems with a variety of medications.

Fast forward to 2014. In May, a large Indian drug manufacturer called Wockhardt had to recall 109,744 bottles of its metoprolol succinate. This company had two of its manufacturing plants shunned by FDA in 2013. Violations in manufacturing meant that products from these facilities could not be exported to the U.S. One of the plants made metoprolol succinate. Until these discoveries, Wockhardt provided one fourth of the metoprolol swallowed by Americans.

Now we are told that another Indian drug company, Dr. Reddy’s Laboratories, also has problems with its metoprolol succinate. It is in the process of recalling 13,560 bottles from the U.S. market. This involves 25 mg tablets from lots C206578 and C207415 (NDC 55111-466-01). In both the Wockhardt and Dr. Reddy’s recall of metoprolol the problem was dissolution. That is, the formulations were not releasing the active ingredient according to FDA specifications.

But here is the rub. Although the FDA considers the Dr. Reddy’s recall important (Class II, which means “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences”) it is doing little to alert patients. Pharmacies are supposed to stop dispensing such products and return them to the company. But patients who have Dr. Reddy’s metoprolol succinate 25 mg pills, even if they are in the recalled lots, are supposed to keep taking them. Huh? Does that make any sense?

Even if you wanted to check on your bottle of pills to see if it was included in the metoprolol recall, the chances are very good that you would not find a lot number. That’s because most state pharmacy rules do not require lot numbers on repackaged pill bottles. Why is it that there are lot numbers on all over-the-counter medications, soup cans and cereal boxes but rarely on a prescription bottle of generic pills? Does that make any sense to you?

Here are some more recent complaints about metoprolol from visitors to our website:

“My metoprolol was usually a small, white, tapered pill. My prescription was refilled with one that was white and aspirin-shaped. After taking only a couple, I experienced an irregular heartbeat. I called the pharmacist and she exchanged the round pills. The problem stopped. When I told my previous doctor what had happened, she said, ‘That couldn’t happen.’ I said, ‘The pharmacist said it could.’ Later my drugstore ran out of the small white tapered pill. I was sent to another drug store to get it refilled. I told the pharmacist what had happened and he said, ‘Of course that happened; the round pill is not time release.'”  E.T., May 16, 2014

“After having a bad reaction to a generic metoprolol in 2007, I began using the AstraZeneca original (Toprol-XL) and then switched to the PAR extended release generic, which is the one authorized by AstraZeneca. It’s more expensive than other generics but I’ve always done well with it (50mg/day), so for me it’s well worth the money. To my knowledge there’s never been an issue with this generic, but I look forward to PP corroborating that.” Gerald, May 16, 2014

“I too had cardiac problems after being on metoprolol for a few years. My GP refused to believe I had problems from the medication. Eventually I was hospitalized. The cardiologist stated that if I had not come to the hospital via 911, I would not have survived.” Marjorie, RN, BA, May 26, 2014

Were this the only generic drug recall in recent years we would not be terribly worried. Unfortunately, dozens of different generic drugs have been recalled. We were instrumental in identifying the problems with generic versions of the antidepressant Wellbutrin XL 300. A generic product called Budeprion XL 300 was eventually withdrawn after we bugged the FDA for years because of reports of generic drug failures by visitors to this website. A different bupropion XL 300 was also withdrawn with little fanfare from the FDA.

To learn more about this tale of woe and intrigue, check out of book, Top Screwups Doctors Make and How to Avoid Them. It provides our “Top 10 Tips for Taking Generic Drugs,” since insurance companies virtually force most Americans to buy generics. We’re not against generic drugs, but we wish the FDA would do a better job both approving bioequivalency and monitoring foreign manufacturers. In the meantime, people will have to take steps to protect themselves. We hope our tips for using generic drugs safely will help.

Share you own generic drug story, positive or negative, below.

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  1. Linda

    I wouldn’t trust ANYTHING made in India. I used to buy a very mild soap called Lowila, made in the U.S. An Indian company (Ranbaxy) started making it and all of a sudden it’s not so mild anymore. When I received the package, I could smell a very strong chemical smell before I even opened the box. Wouldn’t trust them to make soap, let alone a life saving drug.

  2. til

    I have been taking 25 mg each two in morning one at night .
    I have become very tired and increasing headaches.

    I went to have blood pressure taken it is 187 over 88
    I think this is harmful and I complained. I was not happy
    because the doctor said to keep taking the medicine as
    said on perception .

  3. Kelly
    Bentonville , AR

    I’ve been taking this metopropolol for a year now, I swell up, I fall asleep at my desk in the middle of intense work issues that would keep a normal person attentive, ankle, legs, hands swell, I’ve never had seasonal allergies in my life until this last year. I’m lethargic, I don’t want to even do my hobbies anymore. I have had tremendous weight gain and it just keeps climbing. I just thought it was me, I’m only 46, I was a fitness instructor 2 years ago very fit and active, but a crushing foot injury at work halted all that for 8 months. So all this time I’ve been blaming myself for this condition I have, and it very well could be this blood bressure medicine.
    I’m going to my doctor Monday. Thank you all for posting! I feel hopeful and better informed now.


  4. joanne

    So is there a recall on the metoprolol tartrate 25mg?…My daughter started taking it on the 19th of Oct and by 2:45 pm she had a headache and wasn’t feeling good. She passed out inside the hallway of the drs office. Although she was resuscitated, she ended up dying and I’m sure it was because of this med. She had a history of heart problems (vsd), which she had repaired back in 87 when she was a year and a half old. Please respond back. Thank you.

  5. Nancy

    I’ve been on metopropol tartrate for years, I have recently been given a new oblong shaped, white pill, and its like taking nothing, the same with the new blue round pill I was given 3 months prior, my blood pressure shot up,180/100 and higher, my pulse racing, and shortness of breath, I had a few pills left from previous scripts, and had to take one of them. It takes at least 20 min for the pill to finally kick in, and I have to remain quiet and still, because I cannot even move till the pill works. I am going to insist on brand name and nothing else!!!! My side effects are ankle swelling, shortness of breath,heart racing, and exhausted feeling.

  6. elena eritta
    Nesconset, Long Island, New York

    Off shore manufacturing of bogus drugs are an affront to the American people, compromise our health and sends jobs and profits to other countries that are ruthless and act without professional protocol. Govt. intervention is immediately required to insure pure products, bring back manufacturing to our shores and put a cap on non-generic prices…that’s where it all started anyway…”I can get it for you wholesale!” Call/write your reps, your newspapers, your local council people, our president! elena eritta

  7. Patricia

    I was given an RX for Toprol Xl 50 mg about 3 years ago. After about 6 months I was switched to the generic brand Metoprolol 50 mg. I really don’t know whose idea it was – insurance/pharmacy/doctor? – I took the brand name Toprol for almost 2 yrs.

    Not knowing that I was having side effects from this generic drug, I had numerous appointments with my doctor and told her every time about the swelling in my ankles/feet and legs and slow heart rate in the 50’s and sometimes in the 40’s – SOs that was getting worse. I could hardly walk from the car into the store. My blood pressure was still high – 160/90 range. My legs felt weak and like I was walking on 2×4’s. I FELT AWFUL.

    My doctor was not concerned. But I was 69 yrs old and felt like i was getting closer to the grave everyday. Finally I asked a pharmacist which medicine I was taking could cause the low heart rate. I was told it was the Metoprolol. I told him I wanted off of this medicine immediately. I told him all the side effects I was having from this medicine, and he agreed that I should not take it.

    My doctor was called by the pharmacist and told about this problem. I called my insurance company and told them about the problem. I have been taking Toprol xl 50 mgs BRAND for 6 months. B/P is now 120/70 and heart rate 70 – no SOs. No swelling of legs/feet/ankles. I feel like a new person. I am now 71 yrs old and feel very good.

    That generic Metoprolol medicine took 2 yrs of my life away from me. Of course the insurance won’t pay for the brand-name drug but I don’t care. Metoprolol is a terrible, terrible drug. I have told some of my friends, and they have talked to their doctors. It is really sad if you ask me!

    • Joan
      salem nh 03079

      I also have been on metropolol 200mg daily, and my side effects have been awful: stiffness in my legs and can hardly walk some days; nausea, extreme drowsiness, fatigue, and oh, so tired; burning and tingling under my feet after walking; swelling in my ankles and feet; and occasional nightmares.

      I want off of this med. I used to take the brand Lopressor and felt great on it but they suddenly told me I had to go generic, that they were discontinuing the Lopressor. It seems like we all are at the mercy of this med once we are on it. It’s hell trying to get off of it.
      good luck Joan

  8. Jay S.

    Currently take Dr. Reddy’s, 1/2 of a Metoprolol 100MG ER tablet/day. Been taking generics for years. Current 2016 batch seems bad! Lately BP has been 10-20/10 pts higher. Today it’s was +40/10 of normal BP, and +20% of normal rate. Even after x2 doses today, still high…
    WORST was Dr. Watson’s (2013) — such bad headaches, etc that I began bleeding out of both nostrils, streaming down my face (a few times). My Dr. told me that couldn’t happen, that I had probably picked my nose…(NO) I called pharmacy, they told me they recently changed to Dr. Watson’s. Immediately replaced my pills and all returned normal in ~24hrs.

  9. xxxxxx

    I took the generic once and it made me super sick. I was dizzy, sweaty, and I just felt plain gross. I always make sure to get name brand even if it is more expensive and more of a hassle.

  10. Bonnie Christiaens

    I have had problems with the some generic brands also. As long as I stay with the Par brand of
    metoprolol I do great. Some of the generics are not time released and those are the ones that
    cause me problems.

  11. Joseph

    Wow, I have just been reading all the comments about generic drugs, especially Metoprolol Succinate 25mg. I can’t agree more about the state of our pharmaceutical industry. We are all victims of cost savings, no one is looking out for us. I recently started taking the Metoprolol 25mg. (for about 90 days), I developed a very unusual aftertaste. It was a constant metallic smell / taste that grew progressively worse. In addition, I had a very upset stomach. My doctor said it was not the medicine, but if I wanted to, I could stop taking it. It took about a week for the medicine to clear my system, but the strange side effects did pass. I would also like to mention, it did nothing to lower by BP…… I am very curious about all this foreign manufacturing. Is anyone from the FDA regularly policing these facilities. I really doubt it, unless something major happens. The more I read, the more skeptical I am becoming. Please everyone keep sending in your thoughts and information. We need to remain vigilant. How many people are aware of what they are actually ingesting. In many cases the medicine is worse than our condition.

  12. Jerry

    I have been taking Toprol xl for many years with little or no issues. When I moved to another state a few years ago my new doctor felt compelled to move me to a Generic version right away. The new medicine was Metoprolol Succ . I immediately noticed a big difference in how it interacted with my PVC,s and my life in general. I would take the tablet as prescribed in the morning and found myself back on couch sleeping most of day. Later I would snap out of my malaise and just have to deal with my PVC,s increasing . I finally did some research and found that the Medication I had been switched to had been recalled do to production issues concerning the time release and exact dosage irregularities. I took the article to my doctor who remarked and I quote ” So that’s why I am having problems getting this Generic delivered to me on a regular basis”. Not Kidding,,,,,, He then looked at the article I printed and brought it up on his PC and read it in its entirety. I was immediately put back on Toprol xl and all negative symptoms subsided. (I have since gone under a cardiologists watchful eye and no longer use my GP for heart issues.)

    However I am now facing the same situation 5 years later again. My insurance company insists I go on the generic and I have refused as CURRENT articles are reporting even more dire results with the Generics on this medication. I have finally been able to receive Toprol at an acceptable price but I do not know how long before someone steps in again and force me back to the generic.

    I am totally at a loss as to how we must be forced by insurance pricing to use generic medications that are dangerous. Yes I can refuse but I was looking at a 90 day supply at 400 dollars if I do. I could go on but I think you all have gotten a clear picture of what I am up against here. This isn’t an aspirin I am talking about ,,,,its a heartbeat regulating ,,,blood pressure controlling etc etc etc medication. A final point. IF today I was diagnosed for the first time with my condition I would be given this Generic drug to use as a viable medication. It would not work and I would be sent into more testing and even more procedures to address my symptoms. I am fortunate that I have had history and research on my side,,,,, I think……

  13. REBECCA P.

    I have been taking metoprolol succ er 50 mg with no problems, recently our pharmacy started changing labs every time I refilled it. I started with severe palpitations and called the pharmacy, they filled it with another brand. Did ok, now they switched again and I am having the same problem.

    My husband has A-FIB he can’t take the generic due to going into A-FIB.. his doctor switched him to TOPROL, he did fine, then his doctor changed it to the metoprolol succ er 50. When we saw the doctor he said it was the same, there was no way he had problems. I have researched and found they are not exactly the same and a pharmacist told us that the generic has to have the main ingredient, but the law doesn’t require them to have the same amount of it, the fillers are different and react differently with the main ingredient and differently with different people.

    WHEN IS SOMETHING GOING TO BE DONE ABOUT THIS? The drug companies are raising the brand prescriptions to force people to use the generics due to the cost. Maybe it is time the TV CHANNEL started investigating this. We can’t depend on our doctors to stand behind us, the insurance companies will disband them for pushing brands instead of generics.

  14. Laura
    United States

    Began to think I was dying and too stupid to lie down. Have complained of numbers problems to physician, to no avail. Have taken metoprolol ER for more than 25 years. When it was switched to generic is unknown. For last 6 months have had many of the adverse symptoms listed. Why are we getting drugs from foreign countries and not US made?

  15. susan

    Thank you for this article. One of my Metoprolol generics said it was manufactured by Teva USA, which has an Israeli parent, but a subsidiary in the US. In the middle of the night, I’d be woken up by my heart flopping around like a fish on a boat deck. Other nights I’d wake up with a racing heart. I knew it wasn’t me. I never had that problem and I haven’t had it since switching generics. I wrote the FDA and it looked into Teva’s metoprolol and recalled some batches. In other words Teva was distributing bad batches of the drug. Here’s the rub, when the drug was recalled, it was listed as manufactured by Amcare, an Indian company. Teva distributed the drug, but Teva was allowed to list itself as the manufacturer because it did something like buy it in bulk and repackage it. So, these drug companies can head over to India and buy generics from any company, repackage it and list themselves as the manufacturer when in fact, they are not the manufacturer. The consumer has never heard of Amcare, but she thinks Teva is a good name and the next thing she knows she has a malfunctioning heart beat and she’s fearing for her life.

  16. M. Ferreira

    5 years ago I had surgery for 2 hernias, since then the Dr put me on Metoprolol tartrate Brand, few years after the Pharmacy started giving generics, since then I feel very sick and dizzy, I talk to my doctor he says its not from metprolol. M.F
    PS: Sorry my English isn’t too correct, but at least I Try.

  17. SalW

    I get weekly emails from the FDA which include all recalls, but there has not been one mention of this recall. My husband and I recently saw his cardiologist, and he was very interested in all of this information.
    I have to assume there is a problem in getting the message out to the health professionals that need it and also to unsuspecting patients.
    Since generic companies are not required to put lot numbers on their drugs, there is no way to know what to pull from the shelves. I doubt there is any information a pharmacy can get from the FDA if they don’t really believe it is a problem. So, these pills still remain on the shelves because no one thinks there really is a serious problem.
    For our protection, we are staying away from the four pharmaceutical companies in India which have had problems. If no one will protect us, we will do it ourselves.

  18. Bunny

    I have been on Metoprolol succ. ER for a longtime. Recently I came close to running out of my prescription, called my internist to just order what I needed for a short time until my mail order came in. I have always had AstraZeneca and the fill in was from Watson. I had to stop the Watson brand D/T it made me extremely dizzy and could not function. So all generics are not created equal. I did call Watson and reported the issue, my local pharmacy told me to stop taking it.

  19. P Braddock

    I was recently shifted to Metoprolol succinate from another beta blocker and was supplied by my pharmacy with Dr. Reddy’s 50mg round tablet scored, making it possible to reduce one dose to two/25mg doses. Why would only the 25mg version be recalled? Is my supply effective and is it safe?

    • Colleen

      The Dr. Reddy’s metoprolol 50 XL caused my throat to swell after a few days. For a week, I could not figure out what was going on and it was very scary. I reported it to the FDA but am not sure they will do anything. I figure if they cannot figure out how to do extended release in the 25 mg, how could they do it for the 50 mg?

  20. sharon

    I’ve been taking Metoprolol Succ ER for years and it does a good job on my a-fib. However, I’m wondering if it is causing the severe weakness I experience…not tiredness…but weakness. Can anyone help? -sharon

  21. DONNA

    I have been taking metoprolol for a year, and have been noticing a very tired feeling and a much lower blood pressure the last few months… plus the fact the shape of the pill changed recently… I too, will be checking with my mail order delivery service and questioning my doctor about this, and going back to toprol if I can afford it. Thank you for the info……

  22. CarolF

    Kathy, what did you finally settle on instead of the Levoxyl? I haven’t noticed any side effect from the generic but my TSH bounces around and I have had some hair loss. I am known for my thick hair so nobody notices it but me. I never had any symptoms of low thyroid. It was just picked up in a blood test years ago. I would like to go back to Levoxyl but now is it more expensive.

  23. RB

    For women taking Zetia, there seems to be better effectiveness if we also take good quality fish oil. Like ND who commented this morning, I don’t tolerate statins (nor does my sister nor our 3 late brothers). Fish oil helps, as well as providing some relief of arthritic joints.

  24. ND

    I have been on metoprolol succ ER 25 mg for a few years, since I had a minor heart attack (never really sure why I’m on it). Mine are from PAR. I am not aware of any issues for me. It does worry me though that affordable meds may be dangerous. Paying for Plavix was a real problem, I hope there are not problems with the generic. Blood “thinners” have potential for very real danger. Now I have to take Zetia, because each of the three statin drugs I tried caused muscle pain, Zetia is quite expensive. Wish I didn’t need meds.

  25. Teresa

    Why are our drugs being made in foreign countries? We need jobs in this country. I know it’s all about money savings, but how much are you saving if people end up in the hospital, or worse case, dead?
    I too recently had a problem with generic Ziac. Food Lion pharmacy switched generic drug companies in January. It took me a couple of months to realize the generic they switched me to (which I’m sure was a cost savings to Food Lion!) was not working.
    I thought I was going to end up in the ER! I had some of the original generic prescription in my purse and started taking it and my symptoms went away within a couple of days. I went to Food Lion Pharmacy and they switched me back to the original generic. Let’s bring our manufacturing of drugs home.

  26. NBM

    If the response to this topic, on this site, is any indication of the problems with the generic versions of medicines in this country, we are in big trouble!! Something needs to be done, at the national level, to get the FDA’s attention. I would suggest a “Congressional Investigation”, but with the “do nothing Congress” we now have in office, that would be a futile effort. Has PP considered sending the FDA copies of all these complaints?

    • Michelle
      Sol nag California

      This is for NBM… I also had radio ablation in. 2012, I had taken 1 1/2 pills of metropolol Succinate ER 25 mg .. Cut in half… Scrip filled in 4/’12 and MY heartbeat began to skip and flutter and be unstable. I was hospitalized twice in the ER and they gave me SOME shot that worked for about 48 hrs but they said they couldn’t do any more or my ventricles could start going into fib, that I had to have ablation. By luck I live 35 mi from the only place between SF and LA so by luck had someone drive me to the hospital for
      The ablation. It worked- but why did I need it…? Wondering now too if it was the Mylan Co. metropolol succinate ER I took….

  27. LND

    This same thing happened to me with the generic Toprol XL. I was hospitalized twice over irregular heartbeat. This last time I had to be shocked back into rhythm. I had an ablation the first time. They need to do something about this. I am on Sotalol now. Still not working so well.

    • Michelle
      Solvang Californin

      LND-sorry-above comment was meant for you since you had ablation too..

  28. Kathy

    I went through a terrible transition period when Levoxil for my thryroid was taken off the market because it had a funny smell. I had been on the same dose for 30 years. I had heart problems, my blood levels when haywire and after trying three or four other generics and Synthroid. I am balanced again. I am off the heart medication and it has been hard to get the doctor to take the diagnosis of heart problems off my chart, he still wants me on heart medications. KC

  29. Henrietta

    I worry, too. I am the only person at my pharmacy now getting the brand name Avapro. All the other customers are getting the generic version. Wondering what to do if it is no longer manufactured. The brand name is extremely more expensive, but, to me, worth it!

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