Thousands of Blood Pressure Medication Bottles Recalled Nationwide

More than 3,700 bottles of a prescription blood pressure medication are being recalled nationwide after failing quality testing, according to the U.S. Food and Drug Administration. New Jersey-based Macleods Pharma USA initiated the voluntary recall on October 7, and the FDA subsequently classified it as a Class II recall on October 26.

The nationwide recall affects a combination treatment containing olmesartan medoxomil, amlodipine, and hydrochlorothiazide in the 40 mg/10 mg/12.5 mg strength. The impacted inventory totals 3,744 bottles, broken down into 3,528 bottles of 30-count packaging and 216 bottles of 90-count packaging. California's Board of Pharmacy reported that the tablets were distributed between November 21, and April 27.

Health officials stated that the medication failed to meet required dissolution standards during testing, meaning the pills did not dissolve or release their active ingredients at the proper rate inside the body. Specifically, the olmesartan component missed the mark, which could potentially reduce or delay absorption and lead to a temporary dip in blood pressure control for patients.

The FDA defines a Class II recall as a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, and where the probability of serious harm is remote. Although brand-name Tribenzor is not part of the recall, patients taking generic versions are advised to check their prescription labels to ensure their medication is not impacted.

The specific items involved in the recall include 30-count bottles under lot 12251163A with the National Drug Code 33342-246-07, and 90-count bottles under lot 12251163B with the National Drug Code 33342-246-10. Both affected lots carry an expiration date of May 31, 2027.

Medical experts emphasize that patients should not stop taking their blood pressure medication on their own. Consumers are advised to check their lot numbers and contact a pharmacist or doctor immediately for a replacement or if they experience any symptoms suggesting poor blood pressure control.

This safety action follows a separate recall earlier in the year involving thousands of bottles of chlorthalidone tablets by Inventia Healthcare, which also failed dissolution testing and received a Class II classification from the FDA in September.