Recalls / Class II
Class IID-0361-2025
Product
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
- Brand name
- Chlorpromazine Hydrochloride
- Generic name
- Chlorpromazine Hydrochloride
- Active ingredient
- Chlorpromazine Hydrochloride
- Route
- Oral
- NDCs
- 70710-1129, 70710-1130, 70710-1131, 70710-1132, 70710-1133
- FDA application
- ANDA213368
- Affected lot / code info
- Lot #: Z400069, Exp.: 12/31/2025
Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 3144 bottles, pack size: 100's Count
- Distribution pattern
- Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Timeline
- Recall initiated
- 2025-04-03
- FDA classified
- 2025-04-10
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0361-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.