Urgent recall affects 2 popular heart medications sold nationwide

Americans who depend on heart medications are being urged to check their prescriptions after recent safety alerts.

The recalls impact more than 135,000 packages of two widely used treatments for high blood pressure and related conditions.

While regulators say the risks are limited, the warnings highlight potential quality concerns that may affect patients across the country.

For those managing serious health issues, even temporary disruptions in access to safe medication can be unsettling.


The Food and Drug Administration has issued several enforcement reports this month naming two blood pressure medications in separate nationwide recalls.

Together, 135,788 containers have been pulled due to what regulators classified as Class II recalls, which the agency defines as events that may cause temporary or medically reversible side effects, with the chance of serious harm considered remote.

The first drug, Carvedilol, appeared in three FDA reports dated August 12, August 14, and August 21. In total, 114,660 containers of the medication were recalled across the United States.

Carvedilol, often prescribed under brand names like Coreg, is a beta blocker that can help manage high blood pressure, congestive heart failure, or left ventricular dysfunction following a heart attack.


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Urgent recall affects 2 popular heart medications sold nationwide. Image source: Towfiqu barbhuiya / Unsplash


The FDA reports cited manufacturing deviations tied to N-Nitroso Carvedilol Impurity-1, a type of nitrosamine impurity detected above the agency’s recommended limits.

According to the FDA, nitrosamines may carry mutagenic or carcinogenic risks if levels exceed acceptable intake thresholds.

Each lot named in the recall was flagged for exceeding the safe level of this impurity. The affected Carvedilol tablets span multiple dosages, including 3.125 milligrams, 12.5 milligrams, and 25 milligrams.

Lot numbers, expiration dates, and manufacturing details connect the products to Glenmark Pharmaceuticals in India, distributed through Glenmark Pharmaceuticals Inc.


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in New Jersey, with additional lots packaged by Major Pharmaceuticals in Indiana. Separately, the FDA issued a recall notice for 21,128 bottles of Metoprolol Tartrate tablets.

This drug, sometimes known by brand names like Lopressor, is used to lower blood pressure, prevent chest pain, and reduce the risk of further damage after a heart attack.

The reports again cited nitrosamine contamination as the cause, specifically N-nitroso-metoprolol detected above the acceptable daily intake. Like Carvedilol, the issue was linked to deviations from Current Good Manufacturing Practices.

The Metoprolol recall includes 50 milligram and 100 milligram tablets, with batches manufactured by Renata PLC in Bangladesh and distributed by Westminster Pharmaceuticals in Tennessee. Expiration dates for the affected lots range through July 2026.


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This is not the first time Carvedilol has faced quality problems in recent months. In May, more than 732,000 bottles of the medication were recalled under similar circumstances.

The same distributors have also been tied to other recalls earlier this year, including those affecting anxiety medications.

These repeated incidents have kept regulators and patients on alert as new warnings continue to surface.

Read next: Experts reveal the protein-packed food that supports heart health after 60
Key Takeaways

  • The FDA announced nationwide recalls impacting more than 135,000 containers of Carvedilol and Metoprolol.
  • Both drugs are commonly prescribed to treat high blood pressure, heart failure, and post-heart attack conditions.
  • Manufacturing deviations revealed nitrosamine impurities above safe intake limits, prompting Class II recalls.
  • Carvedilol recalls totaled 114,660 containers, while Metoprolol recalls included 21,128 bottles.
Do you currently take either of these medications and plan to check your bottles? Does news like this make you more cautious about relying on generics? Share your thoughts and experiences in the comments.
 

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