FDA Drugs recall ·
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only… recall
- Recall number
- D-0348-2025
- Date
- (initiated March 13, 2025)
- Company / brand
- Glenmark Pharmaceuticals Inc., USA
750 Corporate Dr, Mahwah, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Why was it recalled?
CGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
U.S. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0348-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.