Federal health officials are warning consumers across the country to inspect their medicine cabinets after thousands of bottles of high blood pressure medication were recalled because the tablets failed dissolution testing.
New Jersey-based pharmaceutical manufacturer Macleods Pharma USA initiated the voluntary recall for certain batches of combination tablets containing olmesartan medoxomil, amlodipine, and hydrochlorothiazide, according to enforcement reports from the U.S. Food and Drug Administration.
The agency classified the action as a Class II recall late last month, Fox Business and KOCO reported on Oct. 26, while Newsday cited FDA records noting the classification took place on Oct. 27. Under federal guidelines, a Class II designation indicates that exposure to the product could trigger temporary or medically reversible health issues, while the probability of severe adverse health consequences remains remote.
Affected lots and identification codes
The nationwide recall involves a total of 3,744 bottles distributed across the United States. Federal notices indicate the impacted packages consist of:
- 3,528 30-count bottles from lot 12251163A, labeled with National Drug Code 33342-246-07.
- 216 90-count bottles from lot 12251163B, labeled with National Drug Code 33342-246-10.
Both recalled lots carry an expiration date of May 31, 2027. The FDA cited “failed dissolution specifications” as the root cause of the recall, signifying that the pills did not break down correctly during laboratory testing and might not release their active ingredients as intended.
The triple-combination medication brings together three active agents designed to relax blood vessels and lower elevated blood pressure, according to the Mayo Clinic. Macleods produces the drug as a generic alternative matching the active formulation found in brand-name Tribenzor, while the company also markets it as an equivalent to Benicar HCT, Newsday reported. The FDA has not issued any recall notices for the original brand-name drugs.
Advice for patients taking the medication
Health regulators and patient advocacy organizations caution people against abruptly discontinuing their prescribed regimen without professional medical advice.
For Class II recalls, the FDA typically advises patients to keep taking their prescribed medication unless a doctor or manufacturer explicitly directs them to stop. Medical experts point out that suddenly discontinuing blood pressure therapy can present greater immediate health risks than the recalled drug itself. AARP suggests that patients who identify matching lot numbers on their containers contact their prescribing physician or dispensing pharmacy promptly to arrange a safe replacement prescription before halting treatment. If a bottle lacks an identifiable lot number, consumers should consult their pharmacist directly.
The action marks the second recent high-profile recall linked to dissolution issues among hypertension treatments. Inventia Healthcare, an India-based manufacturer, recalled 13,567 bottles of 25-milligram chlorthalidone tablets in September after the pills also failed dissolution checks, according to the FDA. Representatives for Macleods Pharma USA did not immediately return requests for comment regarding distribution details or potential customer inquiries.
