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 |
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.
How to identify the recalled item
| Lot / date codes | Lot # TY9494, Exp Date: 05/31/2027. |
|---|---|
| Lot / date codes | Lot # TY9494, Exp Date: 05/31/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Apotex Corp. recalls
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.