FDA Issues Class II Recall for Another Blood Pressure Drug

If you take medication to control your blood pressure, this update is worth checking.

The U.S. Food and Drug Administration has posted an enforcement report classifying a nationwide recall of more than 3,700 bottles of blood pressure tablets made by Macleods Pharma USA, Inc. as a Class II recall. The recall, which began earlier in the month, covers two lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets.

Recalled blood pressure tablets

Review your bottle label for the details below to see whether it is part of the recall:

Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets, 40 mg/10 mg/12.5 mg

• 30-count bottle
• NDC: 33342-246-07
• Lot number: 12251163A
• Expiration date: May 31, 2027

Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets, 40 mg/10 mg/12.5 mg

• 90-count bottle
• NDC: 33342-246-10
• Lot number: 12251163B
• Expiration date: May 31, 2027

Why the recall was issued

The FDA says the tablets failed dissolution specifications, meaning they did not meet testing standards for how they dissolve. As a result, the medicine may not work as intended to lower blood pressure. A Class II recall indicates that use of the product could lead to temporary or medically reversible health effects, while the chance of serious harm is considered remote.

What to do if you have this medication

Reach out to your health care provider as soon as possible for advice on whether to keep taking the medicine or obtain a replacement prescription. Do not stop any prescribed medication without first speaking with your doctor.