FDA Drug recall D-0636-2025
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
- FDA Drug
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India by Zydus Pharmaceuticals Usa, citing CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0636-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-03 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Identifiers
| ndc | 70710-1129-1 |
|---|---|
| ndc | 70710-1129-2 |
| ndc | 70710-1129-4 |
| ndc | 70710-1130-1 |
| ndc | 70710-1130-2 |
| ndc | 70710-1130-4 |
| ndc | 70710-1131-1 |
| ndc | 70710-1131-2 |
| ndc | 70710-1131-4 |
| ndc | 70710-1132-1 |
| ndc | 70710-1132-2 |
| ndc | 70710-1132-4 |
| ndc | 70710-1133-1 |
| ndc | 70710-1133-2 |
| ndc | 70710-1133-4 |
| code_info | Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z…Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26 |
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-0636-2025%22
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