FDA Class II Recall Targets 3,744 Bottles of Generic Blood Pressure Meds
The FDA has classified a nationwide recall of over 3,700 bottles of generic blood pressure tablets as Class II. Manufactured by Macleods Pharma USA, the affected lots failed dissolution testing, meaning the pills may not release active ingredients properly. Patients are advised to check lot numbers but continue taking the medication unless directed otherwise by a doctor.
Key points
- The FDA announced a Class II recall for Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide tablets.
- The recall affects two specific lots with expiration dates of May 31, 2027.
- The issue stems from failed dissolution specifications, which may prevent proper release of active ingredients.
- Approximately 3,528 30-count bottles and 216 90-count bottles were dispensed nationwide.
- The FDA advises patients not to stop taking the medication abruptly but to consult their doctors.
Background
This recall follows a separate October recall of Viatris telmisartan tablets. The FDA's classification as Class II indicates that while the probability of serious adverse health consequences is remote, exposure may cause temporary or medically reversible adverse health consequences. The recall was initially initiated by Macleods Pharma USA on October 7, 2026, and classified by the FDA on October 26, 2026.
Why it matters
The recall affects a widely used combination medication for high blood pressure. Patients taking this medication should verify their lot numbers and consult healthcare providers to ensure they receive appropriate treatment without interrupting their medication regimen.
What to watch
Patients should check their prescription bottles for the affected lot numbers (2251163A and 12251163B) and contact their healthcare providers if they have questions about their medication. The FDA will continue to monitor the recall and provide updates as necessary.
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