• On October 26, the FDA issued a Class II recall for over 3,700 bottles of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets manufactured by Macleods Pharma USA due to failed dissolution specifications.
  • The recalled tablets failed to meet dissolution standards during testing, meaning the blood pressure medication may not effectively lower blood pressure as intended for patients relying on it.
  • Patients should immediately verify their bottle's lot number and expiration date against the recall list, then contact their healthcare provider for guidance.

If you take medicine to manage your blood pressure, this is important information.

On October 26, the U.S. Food and Drug Administration (FDA) published an enforcement report giving a Class II designation to a nationwide recall of over 3,700 bottles of blood pressure tablets manufactured by Macleods Pharma USA, Inc. The ongoing recall, which was initiated on October 7, is for two lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets.

Recalled blood pressure tablets

Check any bottle you have for the following information, which identifies the products in each lot:

The recall includes the following products:

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

Reason for the recall

FDA lists the reason as “failed dissolution specifications.” This means the tablets did not meet specifications for how they dissolve during testing, so it may not be effective at lowering blood pressure. Class II status means that if you use or are exposed to a recalled product, you could suffer temporary or medically treatable health effects, or where the probability of serious health consequences is very unlikely.

What to do if you have the recalled medicine

Contact your health care provider right away, and follow their guidance as to whether you should continue taking the medication or get a replacement prescription. Do not stop taking any medication without first talking to your doctor.