FDAFDA · Food and drugs·Recall number D-0877-2026
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
Published October 7, 2026 · Recall initiated: September 23, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PAROXETINE HYDROCHLORIDE
- Manufacturer
- Apotex Corp.
- Distributor
- US Nationwide.
- UPC
- 0360505367436
- Lot
- Lot# TY9495, Exp Date: 05/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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Questions about this recall
Was 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 recalled?
Yes. FDA published recall D-0877-2026 on October 7, 2026. Reported hazard: Failed dissolution specifications.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
How do I know if my unit is part of the recall?
Compare your product details with the notice. Brand: PAROXETINE HYDROCHLORIDE. UPC: 0360505367436.
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