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Generic Toprol XL Recalls Issued Following Years of Complaints

More than 13,500 bottles of generic Toprol extended-release pills distributed by Dr. Reddy’s are being recalled due to concerns about the effectiveness of generic versions of the high blood pressure medication. 

Last week, the FDA announced a Dr. Reddy’s generic Toprol XL recall after the manufacturer’s own tests confirmed that the pills may not dissolve properly.

While no illnesses or deaths have been associated with the recalled generic Toprol tablets, concerns about the effectiveness of the drugs have been raised by doctors for years, according to a report by the New York Times.

The recall affects 13,560 bottles of Metoprolol Succinate Extended Release Tablets, USP 25 mg, sold in 100-count bottles. Two lots of the drug were affected: Lot# C206578 with an expiration date of 05/14. and Lot# C207415 with an expiration date of 06/14.

Pills that do not dissolve properly may fail to deliver the proper dosage of drugs at the proper time, particularly extended release tablets, which are supposed to accurately dissolve over a long period of time, slowly releasing the medication into the body.

This is the second major generic Toprol recall in the last couple months. In May, the FDA announced that Wockhardt USA had sent out a letter in April announcing a Wockhardt generic Toprol XL recall, which affected 109,744 bottles for exactly the same problem.

That recall affected 30-count bottles of Metoprolol Succinate Extended-Release Tablets, USP 50 mg with lot numbers LN10686, LN10687, LN10688, LN10707, and LN10708. All had expiration dates of 02/15.

The recalls come in light of a pending FDA investigational study into the effectiveness of generic Toprol. The agency announced it would award grants for independent researchers to conduct the study following reports that generic Toprol XL was less effective and linked to more side effects than the AstraZeneca brand name drug.

All generic drugs are required to be bioequivalent to the brand-name products they imitate; meaning they should be just as effective and have the same risk of side effects. But since Marck 2009, the FDA has received more than 3,400 adverse event reports involving generic Toprol XL.

However, the reports do not identify which generic versions are causing the problems. The reports only state that the tablets are not AstraZeneca’s brand name version.

Wockhardt manufactured generic Toprol XL at a facility in Mumbai, India, that was banned from shipping drugs to the U.S. in November 2013, after the FDA found out that its workers were providing false information on quality control tests. The facility was also found to be unsanitary. Before the factory was banned from sending drugs to the U.S., it accounted for a quarter of all generic Toprol XL.

The recalled bottles appear to have been shipped to the U.S. before that ban took place. The ban did not include a recall of drugs Wockhardt had already imported to the U.S. from the Mumbai factory.

Novartis also used to manufacture the drug, but stopped following a massive recall in 2008 that affected about 6 million bottles. The recall was issued after the FDA declared that the drug did not meet the agency’s quality standards.

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10 comments

  1. Annette Reply

    My 53 yr old brother takes Toprol XL and so do I. On 8/21/2014 (his birthday) he was rushed from a small county hospital due to pain in his chest to University hospital in Augusta, GA. He had a heart cath as soon as a procedure room became available and during the procedure he arrested on the table. The doctor found no blockages or any problems. He had the same feeling of pressure with chest pain in the doctors office for a checkup 3 weeks lator and he arrested in the office. He had to have a defibrilator/pacemaker put in. After I read that Toprol XL generic can cause many problems similar to his it makes me think that the drug was the problem and all of his problems were VERY unnecessary. I am 66 years old and also take it to help with my blood pressure and have recently noticed I am having palpitations and severe weakness. I am calling my doctor right now to get a check of my heart output.

  2. Beverl Reply

    Believe me the generic for Toprol XL DOES NOT WORK AT ALL! I switched to generic to save money and could feel right away that it was not working. I am 71 and have learned NOT to take any generic drugs, only brand name. Most of the generics are drugs from hell. YOU GET WHAT YOU PAY FOR. It is always worth it to get the brand name.

  3. Carolyn Reply

    I also take Toprol and I know my heart beating slow and I having more Palpitation regular than before and I take the generic kind always going back and forward to the docter with chest pain or what ever they told me everything be fine but since like i am getting worst they told me to take 2 daily instead of one now I have all sort of problem .the insurance won’t pay for the real kind, sometime i feel like my heart is going to stop and it scare me crazy.Whats should i do?

  4. Patti Reply

    After taking Metoprolol ER 100 mg for several years, I’ve begun to experience swelling in my feet. I’ve had to increase my shoe size from 7.5 to 9.5 in order to be able to walk. My feet have become increasingly swollen and sore. I’ve been to two different physicians who never mentioned the side effects of the drug. I learned about it over the internet. All I’ve been told to do is to suck it up and wear support hose!
    I’m looking into natural remedies for high blood pressure and intend to remove myself from the medication. Is there any chance of receiving compensation for the pain and suffering I’ve had to endure?
    I’m 72 and work part-time for the school district as a Para-educator (essentially, a teacher’s assistant). Its tortuous to have to be on my feet most of the day due to the swelling. I also find it extremely upsetting that two physicians never owned-up to what is actually going on. Neither of them advised me of the real cause of the edema in my feet. They seem to be protecting their relationship with the pharmaceutical companies, not their Hippocratic Oath.

  5. Evelyn Reply

    I took metaprolol extended release for about 8 years. I was diagnosed with syncope in 2012. I just had a pacemaker put in this year. I know many people who have taken this for years and either have a pacemaker or afib. Something needs to be done!! This needs to be taken off the market permanently before it kills someone

  6. rebecca Reply

    This medicine has recently left me with severe itching and burning. I have been off it for 3 weeks and still the sensations will not stop. This is horrible. I am trying to find others who are going through the same thing.

  7. Richard Reply

    I took the generic form of metoprolol and blacked out. I am 79 years of age and can no longer drive my car or work becaus of the blackout. I was in the trauma center for three days and Summerlin Hospital in Las Vegas for two days. This happened on June 17, 2016.

  8. Ron Reply

    Have been taking metropolol 50mgg for about one year. On May 5th. 2017 I had my first blackout then went bed for the night.I got up and had breakfast and drove abouto 7 miles for a meetimg when I got ready to leave I passed out again. I could not drive so I called my fiance to come and get me to go home, still not knowing what was wring so I was going to the ERA to get checked out, we’ll I never got the as I passed out again so my fiance called 911 to go to the hospitaleft, while was in the ambulance I had more issue and passed out and was told I FLATLINED for 10 to 12 seconds. I was very lucky that they revived me so that I. Am able to share this so something be done to keep people from dying!!!!. While in the hospital they gave me one more dose of Metropolol 50mg and I passed out for the 5th time in 36 hrs please something has to be done as I ended up with a pacemaker so they saved my life

  9. Carol Reply

    I also have taken Toprol XL for many years. I renewed my prescriptions with the pharmacy and they kept changing to the generic drug. The insurance did not want to pay for the brand name. I felt so out of breath and light headed I discontinued the medication on my own and told the cardiologist prescribe something else because I don’t feel right on this medication.

  10. Ian Reply

    I was on Toprol XL 50mg back in 2004, and suffered a blackout and psychiatric disturbances and hallucinations that got me in trouble with the law. I believe I got an overdose of this medication. A word of warning be careful with this medication!

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