Olmesartan Recall Hits Thousands of Blood Pressure Medication Bottles

Olmesartan recall triggers nationwide safety alert

U.S. health officials have announced a Class II recall of certain Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide tablets after testing revealed they did not meet required dissolution standards. The affected products were distributed across the United States and are identified by specific lot numbers and National Drug Codes.

Blood pressure medication recall details

The recall, initiated by Macleods Pharma USA in early October, includes 3,528 bottles containing 30 tablets each (lot 12251163A) and 216 bottles containing 90 tablets each (lot 12251163B). Both lots carry an expiration date of May 31, 2027. The FDA classified the action as a Class II recall, indicating that use of the medication could cause temporary or medically reversible health effects, though serious outcomes are considered unlikely.

Why the drug recall was issued

Testing showed the pills failed dissolution specifications, meaning they did not dissolve as required during standard quality assessments. This shortfall can affect how the medication is absorbed in the body, potentially leading to reduced efficacy or unexpected side effects.

What patients should check

Consumers are advised to locate the lot number and National Drug Code (NDC) on their prescription bottles. The recalled 30‑count bottles bear NDC 33342‑246‑07, while the 90‑count bottles have NDC 33342‑246‑10. If either identifier matches the recalled information, patients should discontinue use and consult a pharmacist or health‑care provider for a replacement.

FDA olmesartan medoxomil tablet recall context

This action follows a recent recall of another blood‑pressure drug for similar dissolution issues, underscoring heightened scrutiny of manufacturing quality for hypertension treatments.

Product recall impact and next steps

While the recall affects only a fraction of the overall market, the thousands of bottles pulled from shelves represent a significant safety measure. The FDA continues to monitor the situation, and manufacturers are expected to implement corrective actions to prevent future quality failures.

Sources: Fox Business, PhillyBurbs, Yahoo.