Class II · ModerateActive recall
Paroxetine Hydrochloride
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot# TY9495, Exp Date: 05/2027.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed dissolution specifications.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byApotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326 foreign manufacturer
| Brand name | PAROXETINE HYDROCHLORIDE |
| Generic name | PAROXETINE HYDROCHLORIDE |
| Active ingredient(s) | PAROXETINE HYDROCHLORIDE |
| Distributed by / for | Apotex Corp., Weston, Florida 33326 |
| NDC | 60505-1318-3 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Apotex Corp. |
| Distribution | US Nationwide. |
| Recall initiated | 2026-09-23 |
| Report date | 2026-10-07 |
| Recall completed | — |
| Recall number | D-0877-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Weston FL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.