FDAFDA · Food and drugs·Recall number D-0630-2025
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1
Published September 17, 2025 · Recall initiated: September 3, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
What to do
Voluntary: Firm initiated
Recall details
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide in the USA
- UPC
- 0370710112912
- Lot
- Lot #: Z403012, Exp Date 30-04-26; Z406657, Exp Date 30-11-26
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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