Apotex Corp. recalls Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto,
Recalled September 2, 2026 · FDA recall D-0804-2026 · Apotex
Hazard
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria · FDA Class II
Units
6,972 bottles
Sold at
US Nationwide.
Description
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
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
Manufacturer(s)
Apotex Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →