Class II
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
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
- Recall number
- D-0361-2025
- Report date
- April 16, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Generic names
- CHLORPROMAZINE HYDROCHLORIDE
- Brand names
- CHLORPROMAZINE HYDROCHLORIDE
- Product NDCs
- 70710-1129, 70710-1130, 70710-1131, 70710-1132, 70710-1133
Code and lot information
Lot #: Z400069, Exp.: 12/31/2025
Distribution
Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.