Paroxetine Extended-Release Tablets recall (Apotex Corp.)
DrugClass IIOngoing
Summary: Apotex Corp. is recalling 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 60505-1318-3. Reason: Failed dissolution specifications.
What is being recalled
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 60505-1318-3
Why
Failed dissolution specifications.
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# TY9495, Exp Date: 05/2027.
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-0877-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 23, 2026 |
| Reported | October 7, 2026 |
| Company | Apotex Corp. |
| Company location | Weston, FL, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from Apotex Corp. · all drug recalls · recalls from September 2026