RecallRadar

FDA Drug recall D-0347-2025

Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),…

On 2025-04-16 the FDA classified a Class II recall of Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0347-2025
ClassificationClass II
Statusongoing
Initiated2025-03-13
Published2025-04-16
Last updated2026-09-13 11:52 UTC
CompanyGlenmark Pharmaceuticals Usa
DistributionUS

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

Identifiers

ndc72657-157-18
ndc72657-157-36
ndc72657-157-72
ndc72657-157-74
ndc72657-157-76
ndc72657-157-20
ndc72657-157-05
code_infoLot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0347-2025%22

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