Cetirizine Hydrochloride Tablets — Class II drug recall D-0348-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-04-16, distributed nationwide. CGMP Deviations
| Recall number | D-0348-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2025-03-13 |
| Classified | 2025-04-08 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 72657-0128, 72657-0128-03, 72657-0128-04, 72657-0128-08, 72657-0128-14, 72657-0128-15, 72657-0128-18, 72657-0128-24, 72657-0128-30, 72657-0128-35, 72657-0128-41, 72657-0128-45, 72657-0128-60, 72657-0128-70, 72657-0128-81, 72657-0128-82, 72657-0128-84, 72657-0128-86, 72657-0128-90, 72657-0129, 72657-0129-03, 72657-0129-04, 72657-0129-08, 72657-0129-14, 72657-0129-15 and 17 more |
| Lot numbers | 17231980, AUG-25 |
Product
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Reason for recall
CGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0348-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.