Paxil CR recall (Apotex Corp.)
DrugClass IIOngoing
Summary: Apotex Corp. is recalling 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.
What is being recalled
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
Why
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot # TY9494, Exp Date: 05/31/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0804-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 13, 2026 |
| Reported | September 2, 2026 |
| Company | Apotex Corp. |
| Company location | Weston, FL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 6,972 bottles |
More recalls from Apotex Corp. · all drug recalls · recalls from August 2026