Zydus Lifesciences Ltd. and Zydus Pharmaceuticals (USA) Inc. recall Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottles distributed nationwide in the United States. The recall stems from CGMP deviations that allowed N-Nitroso Desmethyl Chlorpromazine to exceed the acceptable intake limit. Health care providers and patients should stop using the product and contact the manufacturer
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Chlorpromazine hydrochloride is an antipsychotic medication used to treat certain psychiatric conditions. It is distributed as a prescription drug and requires pharmacy verification.
N-Nitroso Desmethyl Chlorpromazine is a nitrosamine impurity. Exposure levels above the acceptable intake limit may pose health risks over time.
This recall is not described as part of a broader industry pattern.
Patients must stop using the affected product and seek medical guidance. The recall may require medical substitution and monitoring.
NDC is printed on the bottle label. Recall pages and the FDA enforcement report provide model lists and guidance.
No refunds are specified for prescription drug recalls. Substitutions or guidance will be provided by the manufacturer and clinicians; timelines vary.
Keep the product, packaging, recall notice, and any correspondence with the manufacturer or physician for records
Model numbers affected include Z305079, Z305080, Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Z401158, Z401725, Z401726, Z404118, Z404119, Z404120, Z405648. Sold nationwide in the USA as 100-count bottles of 100 mg chlorpromazine hydrochloride tablets. Sold as Rx only. NDC: 70710-1132-1. Manufacturer: Zydus Lifesciences Ltd. (Baddi, India). Distributed by Zydus Pharmaceuticals (USA) Inc. (Pennington, NJ 08534). Recall date: 2025-09-03.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Mazda North American Operations is recalling 2024 CX-90 and 2025 CX-70 SUVs sold through Mazda dealers. The PCM and ECM software can illuminate malfunction indicator lights and cause a loss of drive power, increasing crash risk. Owner notification letters were mailed December 19, 2024, and Mazda will reprogram the PCM and ECM at no charge.
Mazda North American Operations recalls 2025 Mazda CX-70 plug-in hybrids as software issues in the inverter may cause the malfunction indicator lights to illuminate and a loss of drive power in EV mode. Dealers will update inverter software at no cost. Letters were mailed December 19, 2024.
Mazda North American Operations recalls certain 2024-2025 CX-90 and 2025 CX-70 vehicles with a Dash ESU due to startup function failures. Software reprogramming will remedy the issue at no charge. Owner notices were mailed December 18, 2024. Contact Mazda at 1-800-222-5500 Option 6. NHTSA ID 24V814000.
Subaru recalls 2025 Forester vehicles due to potentially loose child seat anchor bolts. Dealers will inspect and tighten bolts at no charge. Owner letters are expected August 15, 2025. Contact Subaru at 1-844-373-6614. Recall number WRC-25.
Nissan recalls 2025 Pathfinder, Murano and INFINITI QX60 for front brake caliper weakness that could fail. Dealers will inspect and replace calipers as needed, free of charge. Letters sent May 9, 2025. Contact Nissan or INFINITI for remedies.
Mazda North American Operations is recalling 2025 CX-50 Hybrid and CX-50 SUVs sold through Mazda dealers. Incorrectly configured restraint-control software may cause the air bag to deploy improperly. Owner notification letters are expected to be mailed August 17, 2025.
Nissan North America is recalling certain 2025 Nissan Kicks vehicles sold through Nissan dealers nationwide. The certification label may print incorrect GVWR and GAWR values, risking overload. Some SR trims with a 19-inch wheel package may display an incorrect wheel size on the label, and owners should contact their Nissan dealer to arrange replacement labels.
BMW recalls 2025-2026 X1 and X2 models plus MINI Cooper and Countryman variants for front seat belt retractors with damaged torsion bars. The defect may fail to restrain occupants in a crash. Dealers will replace both front retractors at no cost. Owner letters begin November 7, 2025. VIN lookup will be available on NHTSA.gov the same day.