Major Pharmaceuticals recalled 2,064 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall follows the discovery of N-Nitroso Desmethyl Chlorpromazine exceeding safe limits. Consumers must stop using this product immediately and consult healthcare providers for guidance.
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 recalled product includes Chlorpromazine Hydrochloride Tablets, USP, 25 mg, packaged in blister packs of 50 tablets. The affected lots are N01943 and N02025, with an expiration date of February 28, 2026.
The recall results from CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. This chemical poses a significant health risk to consumers.
No specific incidents of injury or illness have been reported in connection with this recall. The contamination risk is classified as high.
Stop using the product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for further guidance.
For more information, visit the FDA website or contact Major Pharmaceuticals directly. Further details are available at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0009-2026.
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