Major Pharmaceuticals recalled 506 blister packs of Chlorpromazine Hydrochloride tablets on September 12, 2025. The recall stems from CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above safe limits. Consumers should stop using the product immediately and consult 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
The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 50 mg, packaged in 100 tablet blister packs. The affected lots are N02009 and N02026 with an expiration date of February 28, 2026. The product was distributed nationwide.
The recall was initiated due to CGMP deviations. N-Nitroso Desmethyl Chlorpromazine levels exceeded the recommended intake limit.
No specific incidents or injuries have been reported in relation to the recalled product. The potential risk remains high due to the hazardous chemical present.
Stop using the recalled tablets immediately. Contact The Harvard Drug Group LLC or your healthcare provider for further guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0011-2026 or call The Harvard Drug Group LLC.
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