FDA Flags Nationwide Recall of Nearly 4,000 Bottles of Blood Pressure Pills

• About 3,700 bottles of a widely used blood pressure medicine have been recalled across the United States, the U.S. Food and Drug Administration (FDA) says.
• The product was found to have “failed dissolution specifications.”
• Here’s how to check whether your medication is included.

If you take medication to help control your blood pressure, it may be worth checking the label. Nearly 4,000 bottles of blood pressure medicine have been recalled nationwide, according to the U.S. Food & Drug Administration (FDA).

The FDA says Macleods Pharma USA, Inc. initiated the voluntary recall because the tablets “failed dissolution specifications.” In other words, the medication may not work as intended because the active ingredients may not be released in the body at the proper rate.

The FDA later classified the recall as Class II, meaning use of the affected product “may cause temporary or medically reversible adverse health consequences.” Here is what to know.

Which products are included in the recall?

The recall covers 3,528 30-count bottles and 216 90-count bottles of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, a generic version of Tribenzor. Check your medicine cabinet for these details:

Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5 mg, 30-count

• 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

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

Additional details are available in the FDA’s enforcement report.

What should you do if you have the recalled medication?

The FDA has not issued specific consumer instructions at this time. If you have any of the recalled blood pressure tablets at home, contact the prescribing doctor before stopping them. If you have already taken the pills and have any concerns about your health, speak with your doctor.