FDA Drug recall D-0160-2025
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ
- FDA Drug
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ by Glenmark Pharmaceuticals Usa, citing CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0160-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-11 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
Reason
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Identifiers
| ndc | 68462-861-01 |
|---|---|
| ndc | 68462-861-10 |
| ndc | 68462-862-01 |
| ndc | 68462-862-10 |
| ndc | 68462-863-01 |
| ndc | 68462-863-10 |
| ndc | 68462-864-01 |
| ndc | 68462-864-10 |
| ndc | 68462-865-01 |
| ndc | 68462-865-10 |
| code_info | Lot#: 17230133, Exp 12/31/2024 |
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-0160-2025%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.