Reported Sep 17, 2025 · Ongoing
Chlorpromazine Hydrochloride Tablets, USP, 100 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, 100 mg, 100-count bottle, Rx only
- Manufactured ByZydus Lifesciences Ltd., Baddi, India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
- NDC70710-1132-1
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Z305079, Z305080, Exp Date 30-09-25 2 Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25 3 Z401158, Z401725, Z401726, Exp. Date 28-02-26 4 Z404118, Z404119, Z404120, Exp Date 30-06-26 5 Z405648, Exp 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Zydus Pharmaceuticals (USA) Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.