Recall: D-0804-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-13Initiated

OngoingStatus

Apotex Corp.Firm

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

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

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.