Hypertension, also known as high blood pressure, is a growing health concern in the U.S. Around 50% of American adults are affected by it, according to health experts, and it’s estimated that only one out of every four adults experiencing high blood pressure currently has it under control. High blood pressure can also lead to more serious concerns, such as heart attack or stroke, says the American Heart Association.

Fortunately, a variety of prescription medications now exist to help. But on Wednesday, the U.S. Food and Drug Administration (FDA) announced a nationwide recall for a medication commonly prescribed to treat high blood pressure.

In the report, a total of 732,960 bottles of Carvedilol tablets are listed, with various dosage amounts. It appears to be the generic for Coreg, and it’s often prescribed to treat high blood pressure and heart failure, according to the Cleveland Clinic.

The problem seems to stem from possible issues during the manufacturing process—the FDA lists “CGMP Deviations; presence ‘N-Nitroso Carvedilol I’ Impurity above the recommended acceptable intake limit” as the official recall reason. CGMP stands for Current Good Manufacturing Practice regulations, which are further defined by the agency on its website.

The recalling firm, Glenmark Pharmaceuticals Inc., USA, in Mahwah, NJ, has been connected to several medication recalls in recent months, including recalls for five different blood pressure medications.

The affected bottles appear to only be available via prescription. Additional details include:

Carvedilol Tablets USP 3.125 mg Tablets, 100-count bottle 

  • Lot Codes and Expiration Dates:
    • Lot 19231450, Exp Mar-25
    • Lot 19233345, Exp Jul-25
    • Lot 19234275, Exp Sep-25
    • Lot 19240280, Exp Dec-25
  • 59,952 total bottles

Carvedilol Tablets USP 3.125 mg Tablets, 500-count bottle 

  • Lot Codes and Expiration Dates:
    • Lots 19231450, 19231464, 19231471, 19231493, Exp Mar-25
    • Lot 19232083, Exp Apr-25
    • Lot 19232658, Exp Jun-25
    • Lots 19233328, 19233343, 19233344, 19233345, Exp Jul-25
    • Lot 19234275, Exp Sep-25
    • Lots 19234843, 19235039, Exp Nov-25
    • Lots 19240280, 19240296, Dec-25
  • 155,976 total bottles

Carvedilol Tablets USP 6.25 mg, 100-count bottle

  • Lot Codes and Expiration Dates:
    • Lot 19233369, Exp Jul-25
    • Lot 19234162, Exp Sep-25
    • Lot 19240543, Exp Jan-26
  • 90,000 total bottles

Carvedilol Tablets USP 6.25 mg, 500-count bottle

  • Lot Codes and Expiration Dates:
    • Lots 19231174, 19231199, Exp Feb-25
    • Lots 19231517,19231527, 19231566,19231568,19231595, 19231618,19231634,19231638, Exp Mar-25
    • Lots 19232043,19232051,19232064, Apr-25
    • Lots 19232322, 19232324, 19232365, 19232380, 19232389, Exp May-25
    • Lots 19232736, 19232743, 19232746, 19232756, 19232757, Exp Jun-25
    • Lots 19233369, 19233371, 19233405, 19233416, Exp Jul-25
    • Lots 19234162, 19234183, 19234192, 19234204, 19234223, 19234243, 19234263, 19234165, 19234242, Exp Sep-25
    • Lots 19234743, 19234774, 19234993, Exp Nov-25
    • Lots 19240223, 19240203, 19240211, 19240214, 19240247, 19240249, 19240272, 19240319, Exp Dec-25
    • Lot 19240543, Exp Jan-26
  • 324,288 total bottles

Carvedilol Tablets USP 12.5 mg, 500-Count bottle

  • Lot Codes and Expiration Dates:
    • Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25
    • Lots 19232226, 19232234, 19232265, 19232271, Exp May-25
    • Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25
  • 84,048 total bottles

Carvedilol Tablets USP 25 mg, 500-Count bottle

  • Lot Codes and Expiration Dates:
    • Lots 19231107, 19231114, 19231152, Exp Feb-25
    • Lot 19234866, Exp Jan-26
  • 18,696 total bottles

The report lists all recalled products as manufactured by Glenmark Pharmaceuticals Ltd. and manufactured for Glenmark Pharmaceuticals Inc., USA.

Though the FDA’s report says the recall was apparently originally initiated on February 28, the agency just assigned a Class II label to the event this week. Class II recalls are for products “that may cause temporary or medically reversible adverse health effects.”

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Molly Jasinski
Molly Jasinski has worked as a writer, editor and social media manager for almost 15 years. She previously worked as an editor for the magazine Birds & Blooms. She’s also held other positions at Trusted Media Brands, working on direct-to-consumer books, editing special interest publications, and assisting with digital production and social me...
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Molly Jasinski