FDAFDA · Food and drugs·Recall number D-0636-2025
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
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 #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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