FDA Media Alert Detail

Drug Recall

FDA Drug Recall: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: A...

  • U.S. Food and Drug Administration
  • September 2, 2026
  • ID: D-0804-2026

Drug Enforcement Report Details

Recall NumberD-0804-2026
Recalling FirmApotex Corp.
ClassificationClass II
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternUS Nationwide.
StatusOngoing
Product Description

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

Code Information

Lot # TY9494, Exp Date: 05/31/2027.


Content syndicated from the U.S. Food and Drug Administration (FDA) drug enforcement reports database.