Zydus Pharmaceuticals (USA) Inc 2025-09-17 Health serious FDA
Health · FDA · Recall #FDA-D-0634-2025
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured… Recall
Issued September 17, 2025 · Zydus Pharmaceuticals (USA) Inc
In September 2025, Zydus Pharmaceuticals (USA) Inc recalled the Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
What you should do
- 1 Stop using Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Zydus Pharmaceuticals (USA) Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Zydus Pharmaceuticals (USA) Inc
- Category
- Health
- Recall date
- September 17, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0634-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Zydus Pharmaceuticals (USA) Inc has 31 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.