Macleods Pharma Usa, Inc: Olmesartan Medoxomil, Amlodipine, And Hydrochlorothiazide Tablets 40 Mg/10 Mg/12.5mg, Packaged As A) 30-count Bottle

Recalling firm
MACLEODS PHARMA USA, INC
Product
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg, packaged as a) 30-count bottle, NDC 33342-246-07; b) 90-count bottle, NDC 33342-246-10; Rx Only, Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd, Daman, 396210, India
Reason
Failed Dissolution Specifications.
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-10-07
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/50b55e68-8374-4439-9e13-0afaccadbea1