FDA Drug recall D-0348-2025
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon
- FDA Drug
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0348-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-13 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Identifiers
| ndc | 72657-128-30 |
|---|---|
| ndc | 72657-128-45 |
| ndc | 72657-128-60 |
| ndc | 72657-128-70 |
| ndc | 72657-128-90 |
| ndc | 72657-128-08 |
| ndc | 72657-128-14 |
| ndc | 72657-128-15 |
| ndc | 72657-128-18 |
| ndc | 72657-128-24 |
| ndc | 72657-128-03 |
| ndc | 72657-128-35 |
| ndc | 72657-128-04 |
| ndc | 72657-128-81 |
| ndc | 72657-128-82 |
| ndc | 72657-128-84 |
| ndc | 72657-128-86 |
| ndc | 72657-128-41 |
| ndc | 72657-129-30 |
| ndc | 72657-129-45 |
| ndc | 72657-129-60 |
| ndc | 72657-129-70 |
| ndc | 72657-129-90 |
| ndc | 72657-129-08 |
| ndc | 72657-129-14 |
| ndc | 72657-129-15 |
| ndc | 72657-129-18 |
| ndc | 72657-129-24 |
| ndc | 72657-129-03 |
| ndc | 72657-129-35 |
| ndc | 72657-129-04 |
| ndc | 72657-129-81 |
| ndc | 72657-129-82 |
| ndc | 72657-129-84 |
| ndc | 72657-129-86 |
| ndc | 72657-129-41 |
| ndc | 72657-130-05 |
| ndc | 72657-131-89 |
| code_info | Lot # 17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart 17241436, ep.. date Jul-26 Amazon 17241437…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0348-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.