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
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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.
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