Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
Reported: September 17, 2025 Initiated: September 3, 2025 #D-0635-2025
Product Description
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
Reason for Recall
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- N/A
- Distribution
- Nationwide in the USA
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: N/A.
Why was this product recalled? ▼
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 17, 2025. Severity: Moderate. Recall number: D-0635-2025.
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