Blood pressure medication recalled as it may be ineffective, FDA says

Macleods Pharmaceuticals recalled 3,744 bottles of Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets nationwide after testing found the olmesartan component did not meet dissolution specifications on two lots. The FDA classified it as a Class II recall on October 26, meaning exposure may cause temporary or medically reversible adverse health consequences. The affected tablets could reduce or delay absorption, potentially causing a temporary reduction in blood pressure control. The recall covers 30-count and 90-count bottles distributed between November 2025 and April 2026.

Recall details

• ▪Macleods Pharmaceuticals initiated the recall on October 7
• ▪The nationwide recall covered 3,744 bottles of Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets
• ▪The FDA categorized it as a Class II recall on October 26
• ▪More than 3,700 bottles of blood pressure medication are being recalled because they may be ineffective

Dissolution testing failure

• ▪Testing found that the olmesartan component did not meet dissolution specifications on two lots
• ▪Failure to meet dissolution specifications could mean a less effective medication or incorrect dosage
• ▪Dissolution testing checks how well a drug dissolves and releases when placed in a liquid

Medication background

• ▪Olmesartan medoxomil, amlodipine and hydrochlorothiazide is a combination of medicines used to treat high blood pressure

FDA classification

• ▪A Class II recall means exposure to the product may cause temporary or medically reversible adverse health consequences

Affected products

• ▪The 90-count bottles have NDC 33342-246-10, lot number 12251163B, expiration date May 31 2027
• ▪The 30-count bottles have NDC 33342-246-07, lot number 12251163A, expiration date May 31 2027
• ▪The recall impacts 30-count and 90-count bottles of the medication
• ▪The recalled tablets were distributed between November 21 2025 and April 27 2026

Health impact

• ▪The affected tablets could reduce or delay absorption of olmesartan, potentially causing a temporary reduction in blood pressure control

Debatable claims

• ▪FDA drug quality testing catches failures too late to protect patients
• ▪The Class II recall category lets ineffective drugs remain on shelves too long