FDA Issues Nationwide Recall for Over 3,000 Bottles of Blood Pressure Medication

The U.S. Food and Drug Administration (FDA) has issued a nationwide recall for several lots of a three-in-one blood pressure medication after the pills failed to meet federal quality standards.

Recall Details

Macleods Pharma USA, Inc., a New Jersey-based company, is recalling certain lots of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets. The medication is a combination of olmesartan and amlodipine, which help relax blood vessels, and hydrochlorothiazide, a diuretic that helps the body eliminate excess salt and water, according to Yahoo.

The recall includes the following specific products:

• 30-count bottles: NDC 33342-246-07, Lot number 12251163A, expiring May 31, 2027.
• 90-count bottles: NDC 33342-246-10, Lot number 12251163B, expiring May 31, 2027.

According to Fox Business, the recall covers 3,528 30-count bottles and 216 90-count bottles. Yahoo reports the total number of recalled bottles is 3,744.

The FDA listed the reason for the recall as "failed dissolution specifications," which means the pills did not dissolve as required during testing. This issue could affect how the body absorbs the medication.

FDA Classification

The FDA classified the action as a Class II recall. In an October 26 report, the agency defined a Class II recall as a situation where use of the affected medication "may cause temporary or medically reversible adverse health consequences" but the likelihood of serious health consequences is considered remote, according to Fox Business. Yahoo notes that the FDA defines it as a drug that "may cause temporary health consequences, but the probability of a serious health issue is remote."

Macleods Pharma USA initiated the recall on October 7, and the FDA classified it on October 26. The recall remains ongoing. While the FDA notes that people can generally continue taking medications affected by Class II recalls, patients should check with their doctor or pharmacist for guidance first, according to Yahoo.

Context of Recent Recalls

This recall follows several other recent instances of blood pressure medication being pulled from shelves due to similar quality issues.

In September, India-based Inventia Healthcare Ltd. recalled 13,567 bottles of 25-milligram chlorthalidone tablets after the medication failed dissolution testing, according to the FDA. Chlorthalidone is used to treat high blood pressure and fluid retention, according to Mayo Clinic.

Additionally, Yahoo reports that an October recall affected more than 21,000 bottles of a separate combination blood pressure pill.

Why it matters

Managing high blood pressure can be complex; Harvard Health reports that up to 30% of people with high blood pressure require three different drugs to help keep it under control.

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Sources

• foxbusiness.com: Blood pressure medicine recall: Thousands of bottles pulled nationwide | Fox Business
• yahoo.com: FDA: More Than 3,000 Bottles of Blood Pressure Drug Recalled Nationwide

This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.