Recall D-0804-2026

US Class II Ongoing · initiated 2026-08-13

Recalling firm

Apotex Corp., FL

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

Reason for recall

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

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