Macleods Pharma USA is recalling 3,744 bottles of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets after federal testing found the pills failed dissolution specifications. The action covers 3,528 30-count bottles from lot 12251163A and 216 90-count bottles from lot 12251163B, both expiring May 31, 2027.
The recall is drawing attention now because the tablets were shipped nationwide and are part of a prescription blood pressure treatment people may already have at home. The 30-count bottles carry NDC 33342-246-07, while the 90-count bottles carry NDC 33342-246-10, giving patients and pharmacists two lot-and-package combinations to check against the recall notice.
The problem was not a labeling error or a storage issue. The FDA said the pills did not dissolve as required during testing, which matters because a tablet that breaks down too slowly, or not at all as expected, may not release the drug properly in the body. That can weaken the medication’s effect even when the dose on the label looks correct.
Still, the agency classified the case as a Class II recall on Oct. 26 and said use of the affected medicine may cause temporary or medically reversible adverse health consequences, while serious health consequences are considered remote. That is the friction in this recall: the product failed quality standards, but regulators did not place it in the most severe category.
Macleods Pharma USA initiated the recall on Oct. 7, and the action remains ongoing. The timing also follows a similar recall in September, when Inventia Healthcare Ltd. pulled 13,567 bottles of 25-milligram chlorthalidone tablets after failed dissolution testing, underscoring that the latest pullback is part of a broader quality problem affecting blood pressure medicines. What remains unanswered is how many patients already received the recalled bottles before the notice went out, and who will be checking their medicine cabinets now that the product is still in circulation.
