Recalls / Class II
Class IID-0348-2025
Product
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
- Brand name
- Cetirizine Hcl
- Generic name
- Cetirizine
- Active ingredient
- Cetirizine Hydrochloride
- Route
- Oral
- NDCs
- 72657-128, 72657-129, 72657-130, 72657-131
- FDA application
- ANDA078427
- Affected lot / code info
- Lot # 17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart 17241436, ep.. date Jul-26 Amazon 17241437, ep.. date Jul-26 Amazon 17241455, ep.. date Jul-26 Amazon 17241456, ep.. date Aug-26 Amazon 17241457, ep.. date Aug-26 Amazon 17241892, ep.. date Oct-26 Amazon 17241893, ep.. date Oct-26 Amazon
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- GLENMARK THERAPEUTICS INC., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-13
- FDA classified
- 2025-04-08
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0348-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.