Reported Sep 17, 2025 · Ongoing
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only
- Manufactured ByZydus Lifesciences Ltd., Baddi, India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
- NDC70710-1131-1
- Lot codes and dates
Lot #: Z306327Exp Date 30-11-25Z306748Exp Date 30-11-25Z401154Exp Date 28-02-26Z403738Exp Date 31-05-26Z405645Exp Date 30-09-26
- Amount recalled
- N/A
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
This product could cause temporary or reversible health problems — stop using it.
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