Drug recall D-0634-2025
Product
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
Reason for recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots and codes
Lot #: Z306327, Exp Date 30-11-25; Z306748, Exp Date 30-11-25; Z401154, Exp Date 28-02-26; Z403738, Exp Date 31-05-26; Z405645, Exp Date 30-09-26
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- N/A
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 3, 2025
Related products
- Chlorpromazine Hydrochloride – drug information
- NDC 70710-1133 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 200 mg/1 · Zydus Pharmaceuticals (USA) Inc.
- NDC 70710-1132 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 100 mg/1 · Zydus Pharmaceuticals (USA) Inc.
- NDC 70710-1130 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 25 mg/1 · Zydus Pharmaceuticals (USA) Inc.
- NDC 70710-1129 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 10 mg/1 · Zydus Pharmaceuticals (USA) Inc.
- NDC 70710-1131 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 50 mg/1 · Zydus Pharmaceuticals (USA) Inc.