Recall: D-0348-2025

Class II - Potentially Harmful

Class IIClassification

2025-03-13Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

Product

Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35

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.