Class II
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Recall number
- D-0639-2025
- Report date
- September 17, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Generic names
- CHLORPROMAZINE HYDROCHLORIDE
- Brand names
- CHLORPROMAZINE HYDROCHLORIDE
- Product NDCs
- 16714-047, 16714-048, 16714-049, 16714-050, 16714-051
Code and lot information
Lot #: Z305085, Exp Date 30-09-25; Z401166, Z401167, Exp Date 28-02-26
Distribution
Nationwide in the USA
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.