Regulators have issued a recall for more than 3,700 bottles of blood pressure medication after it failed safety tests. The three-in-one pill, which contains olmesartan, amlodipine, and hydrochlorothiazide to relax the blood vessels and eliminate excess water, failed dissolution tests, meaning it may not be absorbed by the body as intended.
FDA Recall Details
The US Food and Drug Administration (FDA) issued the recall of the pills, manufactured by Macleods Pharma USA, Inc., in October. Some 3,744 bottles are affected. The pills were available across the US.
It is a class II recall, which the FDA defines as: “A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Affected Products and Next Steps
Details of the affected Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets (40 mg/10 mg/12.5 mg) are:
- 30-count bottles — NDC: 33342-246-07, Lot number: 12251163A, Expiration date: 05/31/2027
- 90-count bottles — NDC: 33342-246-10, Lot number: 12251163B, Expiration date: 05/31/2027
The manufacturer issued the recall voluntarily via the FDA. Patients should contact their pharmacy if they believe they have any of the affected pills.
