Major Pharmaceuticals recalled 1,394 blister packs of Chlorpromazine Hydrochloride Tablets due to contamination concerns. The recall occurred on September 12, 2025, after the FDA found N-Nitroso Desmethyl Chlorpromazine above acceptable limits. Consumers should stop using these tablets and seek guidance from healthcare providers.
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recall includes Chlorpromazine Hydrochloride Tablets, USP, 200 mg, packaged in 100 tablets per blister pack. The affected lots include N01928, N02008, and N02071, with expiration dates ranging from February 28, 2026, to March 21, 2026.
The product contains N-Nitroso Desmethyl Chlorpromazine, which exceeds the recommended intake limit. This contamination poses a serious health risk to consumers.
No specific incidents or injuries have been reported related to this contamination at this time. However, the presence of the hazardous substance necessitates immediate action.
Stop using the product immediately. Contact Major Pharmaceuticals or your healthcare provider for guidance regarding this recall.
For more information, call The Harvard Drug Group LLC at 1-800-XXXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0013-2026.
Get instant alerts for recalls that affect you. Free forever.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.
Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.