FDA Drug · D-0804-2026

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

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot # TY9494, Exp Date: 05/31/2027.

Recalling firm: Apotex Corp., Weston, FL
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 6,972 bottles
Distribution: US Nationwide.
Recall initiated: August 13, 2026
Classified: August 27, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0804-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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