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CLASS II · ModerateFDA

Apotex Corp. recalls Paroxetine Extended-Release Tablets

📅 Sep 23, 2026 · 📍 Nationwide
Recalling company
Apotex Corp.
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
Failed dissolution specifications.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 23, 2026
Reported
Oct 7, 2026
Distribution
US Nationwide.
Status
Ongoing
Lot / codes
Lot# TY9495, Exp Date: 05/2027.
Company location
Weston, FL
Recall type
Voluntary: Firm initiated
Recall number
D-0877-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0877-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.