Drug recall D-0636-2025
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 for recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots and codes
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
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.