Apotex Corp. Paxil CR Paroxetine Extended-Release Tablets 37.5mg Recall
Announced 2026-09-02 · FDA
Apotex Corp. is recalling Paxil CR Paroxetine Extended-Release Tablets 37.5 mg, 30-count bottles (Rx only) distributed nationwide in the U.S. due to failed dissolution specifications and failure to meet 24-month stability testing acceptance criteria for Lot TY9494, Exp 05/31/2027. About 6,972 bottles are affected.
| Brand | Apotex Corp. |
|---|---|
| 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 |
| Severity | moderate |
| Units affected | 6972 |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Lot # TY9494, Exp Date: 05/31/2027. |
WHAT YOU SHOULD DO
- Stop using any Paxil CR 37.5 mg bottles from Lot TY9494.
- Contact your pharmacist or healthcare provider for a replacement or refund and disposal instructions.
- Check your bottle's lot number TY9494 and expiration date 05/31/2027 to confirm if affected.
- Follow recall updates from the FDA or Apotex for return or disposal instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.