More than 3,700 bottles of a generic blood pressure medication have been recalled nationwide after the tablets failed quality tests, the U.S. Food and Drug Administration said.
Macleods Pharma USA, the New Jersey-based subsidiary of India's Macleods Pharmaceuticals, initiated the recall on October 7. On October 26, the FDA categorized it as a Class II recall, meaning use of the drug "may cause temporary or medically reversible adverse health consequences, but the probability of a serious health issue is remote."
The recall covers two lots of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets — a three-drug combination pill, the generic version of the brand-name drug Tribenzor. The 30-count bottles, lot 12251163A, number 3,528; the 90-count bottles, lot 12251163B, number 216. Both lots expire May 31, 2027.
The FDA listed the reason as "failed dissolution specifications" — the tablets did not break down correctly during testing, creating a risk that the medicine releases its active ingredients too slowly and lowers blood pressure less effectively than intended.
The brand-name product Tribenzor is not part of the recall; only the two listed lots of the Macleods generic are included. No injuries, confirmed treatment failures, or adverse-event counts tied to these lots have appeared in the public record. For Class II recalls, patients can generally keep taking the medicine unless the company or the FDA says otherwise — anyone whose bottle matches should check with their pharmacist.
The recall is the latest in a series of blood pressure drug quality problems this fall, including separate recalls of other amlodipine combinations over dissolution and potency issues.
