Apotex Corp. — Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., We

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

Provider: FDA — drug enforcement reference
Source observed: 9/2/2026, 12:00:00 AM UTC
Source updated: 9/2/2026, 12:00:00 AM UTC
Location: Weston, FL, US
hazard: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
distribution: US Nationwide.
manufacturer: Apotex Corp.
recall number: D-0804-2026
source status: Ongoing
classification: Class II
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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