Drug FDA Class II Ongoing cGMP deviation
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01
Zydus Pharmaceuticals (USA) Inc Published Sep 17, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Hazards
N-Nitroso Desmethyl Chlorpromazine · primary
Affected products (1)
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01
CHLORPROMAZINE HYDROCHLORIDE · N/A
NDC: 16714-047, 16714-048, 16714-049, 16714-050, 16714-051, 16714-047-01, 16714-048-01, 16714-049-01, 16714-050-01, 16714-051-01
Code info: Lot #: Z305062, exp 31-08-25; Z306324, Exp Date 30-11-25; Z401151, Z401152, Exp Date 28-02-26
Affected areas
Nationwide
Timeline
- InitiatedSep 3, 2025
- PublishedSep 17, 2025
- Recall number
- D-0633-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.