FDA Recalls Blood Pressure Medications Nationwide Over Quality Issues

WASHINGTON — The U.S. Food and Drug Administration has issued two separate recalls of blood pressure medications this fall, citing quality control issues with dissolution specifications and tablet potency.

The first recall involves 3,744 bottles of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets (40 mg/10 mg/12.5 mg) distributed by Macleods Pharma USA. The FDA classified the recall as Class II, meaning the drug may cause temporary health consequences but the probability of a serious health issue is remote. The recall stems from failed dissolution specifications, meaning the tablets did not dissolve as expected during testing. Affected products include 30-count bottles with NDC 33342-246-07 and lot number 12251163A, and 90-count bottles with NDC 33342-246-10 and lot number 12251163B, both with expiration dates of 05/31/2027.

The FDA notes that patients can generally continue taking medications affected by Class II recalls, though they should always check with their doctor or pharmacist for guidance first. Macleods Pharma has not issued a press release or specific consumer instructions regarding this recall.

The second recall affects over 20,000 bottles of telmisartan and amlodipine combination tablets distributed by Mylan Pharmaceuticals. This recall was classified as a Class III recall, meaning consumption of the medication is not likely to cause adverse health consequences. The recall was initiated due to superpotency issues, where the telmisartan content in the tablets exceeds specifications. Affected lot numbers include 3228113, 3228114 and 3228115 with an expiration date of October 31, 2026, and lot numbers 3228120 and 3228121 with an expiration date of November 30, 2026. The tablets were distributed in 30-count bottles by prescription only.

Patients taking either recalled medication are advised to check their prescription bottles for lot numbers and consult with their doctor or pharmacist. Those with affected products may be able to return them to their pharmacy for a refund. This series of recalls follows earlier blood pressure medication recalls in September and October involving chlorthalidone and other combination pills.