FDA-Drug2026-10-07Class IIPROCESSING DEFECT
Apotex Paroxetine Extended-Release 37.5mg tablets recalled for failed dissolution
What this means
Apotex Corp. is recalling Paroxetine Extended-Release Tablets 37.5mg (Lot# TY9495, Exp Date 05/2027) because they failed to meet dissolution specifications. This means the tablets may not break down properly in the body, affecting how much medicine is absorbed.
- Check if you have this medication (NDC 60505-1318-3, Lot# TY9495).
- Contact your pharmacy or doctor before stopping this medication.
- Do not flush or throw away tablets; ask your pharmacy how to safely dispose of them.
The agency's original wording
Hazard
Failed dissolution specifications.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Manufactured in
2400 N Commerce Pkwy Ste 400, Weston, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0877-2026More Apotex recalls
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