PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: April 16, 2025 Initiated: March 13, 2025 #D-0347-2025

Product Description

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 for Recall

CGMP Deviations

Details

Units Affected
N/A
Distribution
U.S. Nationwide
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: N/A.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on April 16, 2025. Severity: Moderate. Recall number: D-0347-2025.