FDA recall D-0877-2026 · Oct 7, 2026
Apotex Corp.: Paroxetine Extended-Release Tablets recall
Product
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 for recall
Failed dissolution specifications.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your package, and look for the company's notice on FDA's recalls page. If you have the product and aren't sure, don't use it until you've checked.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot# TY9495, Exp Date: 05/2027.
- Distribution
- US Nationwide.
- Recalling firm
- Apotex Corp., Weston, FL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-23
Source: openFDA enforcement record D-0877-2026 · search recall number D-0877-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 14, 2026, 12:58 AM EDT. The agency notice is the final word.
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