Drug recall D-0638-2025
Product
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
Reason for recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots and codes
Lot #: Z305083, Z305084, Z305468, Z305469, Z305470, Exp Date 30-09-25; Z401163, Z401165, Exp Date 28-02-26; Z402217, Z402218, Exp Date 31-03-26; Z405518, Z405520, Exp Date 31-08-26; Z406235, Exp Date 31-10-26
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.