Understanding the Verapamil Recalls
Verapamil, a calcium channel blocker used to treat hypertension and certain heart conditions, has been the subject of several recalls in recent years. Unlike a complete market withdrawal, these were specific recalls affecting particular batches from different manufacturers. These instances highlight the rigorous standards and continuous oversight within the pharmaceutical industry, where even minor deviations can trigger a recall to ensure patient safety and product efficacy.
The U.S. Food and Drug Administration (FDA) is responsible for designating a recall classification based on the potential health risk. A Class II recall indicates a situation where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, with a remote possibility of serious harm. A Class III recall is for products that violate federal regulations but are unlikely to cause adverse health consequences. All of the recent verapamil recalls have fallen into one of these two classifications, not the more severe Class I classification.
A Chronology of Recent Verapamil Recalls
Several distinct manufacturing issues have led to verapamil recalls by different companies. Each recall is initiated for a specific reason and affects a specific set of drug lots.
Amerisource Health Services Recall (2023)
In March 2023, Amerisource Health Services initiated a voluntary Class II recall of certain lots of verapamil hydrochloride extended-release tablets.
- Reason: The recall was due to out-of-specification dissolution results, meaning the tablets were not dissolving as intended to release the medication over the specified extended period. This could lead to a different rate of drug absorption than prescribed.
- Affected Product: Verapamil hydrochloride extended-release tablets, 180 mg, 100-tablet cartons (NDC 60687-504-01) from lots 1008622 and 1010026.
- FDA Classification: Class II, indicating potential for temporary or reversible health consequences.
Glenmark Pharmaceuticals Recalls (2023 & 2025)
Glenmark Pharmaceuticals has issued multiple recalls for their verapamil products.
- 2023 Recall: In August 2023, Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets. This was a Class III recall prompted by stability testing that found the drug to be subpotent at the three-month mark.
- 2025 Recall: Another recall affecting Glenmark's verapamil extended-release tablets was reported in July 2025 and mentioned again in early September 2025 by local health authorities. The reasons for this specific recall in 2025 align with previous manufacturing issues.
Zydus Pharmaceuticals Recall (2024)
In July 2024, Zydus Pharmaceuticals recalled multiple lots of verapamil hydrochloride injection due to potential cross-contamination with other products.
- Reason: The contamination issues stemmed from cleaning deficiencies at the manufacturing facility in India, which was classified as "Official Action Indicated" (OAI) by the FDA.
- Affected Product: Multiple lots of Verapamil Hydrochloride injection.
- FDA Action: The recall followed an FDA inspection that identified significant quality control issues, particularly regarding cleaning procedures.
The Difference Between a Recall and Market Withdrawal
It is crucial to differentiate between a targeted recall and a broad market withdrawal based on inherent drug safety issues. These verapamil recalls were due to manufacturing process defects, not the drug's fundamental safety profile. Indeed, the FDA has previously determined that older versions of verapamil tablets were not withdrawn for safety or effectiveness reasons, allowing for generic versions to remain on the market. Today, various generic versions of verapamil are widely available and covered by most insurance plans, reinforcing that the drug as a whole is not under a safety cloud.
Comparison of Recent Verapamil Recalls
| Feature | Amerisource (2023) | Glenmark (2023) | Zydus (2024) |
|---|---|---|---|
| Manufacturer | Amerisource Health Services (via American Health Packaging) | Glenmark Pharmaceuticals Inc. | Zydus Pharmaceuticals (USA) Inc. |
| Reason | Out-of-specification dissolution results | Subpotent at 3-month stability test | Potential cross-contamination |
| Affected Product | Extended-release tablets (180 mg) | Combo extended-release tablets (2 mg/180 mg) | Hydrochloride Injection |
| FDA Classification | Class II | Class III | Followed FDA OAI Classification |
| Potential Harm | Temporary or reversible adverse health consequences | Use not likely to cause harm | Risk of harm from cross-contaminating product |
Patient Guidelines and Actions
If a patient has a recalled lot of verapamil, they should follow the specific instructions from their pharmacy or healthcare provider. The FDA provides detailed information on all drug recalls.
- Stop Taking Recalled Lots: Patients should not stop taking their medication suddenly without consulting a doctor, as this can be dangerous, especially with blood pressure medication.
- Contact Provider: Contact a doctor or pharmacist to determine if your specific prescription is affected and to receive a replacement prescription.
- Safe Disposal: Dispose of the recalled medication according to local pharmacy guidelines.
Conclusion
The medication verapamil has been subject to multiple, specific product recalls from different manufacturers due to quality control issues like subpotency and contamination. These are not related to the core safety of the active ingredient but rather to isolated manufacturing failures. Patients should remain vigilant and confirm with their pharmacist or healthcare provider that their specific medication lot is not part of a current recall. It is important to emphasize that verapamil remains a safe and effective treatment for many people, and these recalls do not warrant stopping the medication without professional medical guidance. For more information, the U.S. Food and Drug Administration maintains a public database of all drug recalls based on manufacturer reports and inspections.
