Drug & medication recalls Moderate risk

Acetaminophen and Ibuprofen Tablets recalled over manufacturing violations

Recall date
March 13, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Glenmark Pharmaceuticals Inc., USA recalls Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count pac…
Recall number
D-0347-2025
FDA classification
Class II
Brand / firm
Glenmark Pharmaceuticals Inc., USA
Sold / distributed
U.S. Nationwide

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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