Macleods Pharma USA began an Amlodipine recall on Oct. 7 after certain lots of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets failed federal quality testing. The action covers 3,744 bottles distributed nationwide.
The recall includes 3,528 30-count bottles from lot 12251163A and 216 90-count bottles from lot 12251163B. Both lots expire May 31, 2027.
FDA Class II classification
The FDA classified the recall as Class II on Oct. 26. In FDA terms, that category covers products that may cause temporary or medically reversible adverse health consequences, while serious health consequences are considered remote.
The bottles tied to the 30-count package carry NDC 33342-246-07, and the 90-count package carries NDC 33342-246-10. For a prescription blood pressure medicine, the testing result points to a practical concern: the tablets did not dissolve as required, so the product did not meet the federal standard that supports how the medicine is released in the body.
Inventia Healthcare Ltd. recall
That complication echoes a separate September recall by India-based Inventia Healthcare Ltd., which pulled 13,567 bottles of 25-milligram chlorthalidone tablets after the medication failed dissolution testing. The two actions show the same type of quality problem, even though the products are different.
The current recall remains ongoing. Patients and consumers who have bottles matching the recalled lots or NDC numbers should check them against the package information on hand and follow the recall action tied to those specific bottles.
The one unanswered point is whether any patients experienced reduced blood pressure control or other effects before the recall. The recall itself says the tablets failed dissolution specifications; the classification also places the health risk in a lower-severity category.
