Recall: D-0347-2025

Class II - Potentially Harmful

Class IIClassification

2025-03-13Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

Product

Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India

Reason

CGMP Deviations

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.