Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Paroxetine Hydrochloride Tablets USP Recalled by Apotex Corp. Due to Failed Impurities/Degradation Specifications-Out of specification (OOS) results for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Apotex Corp. directly.
Affected Products
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Quantity: 34,392
Why Was This Recalled?
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Apotex Corp.
Apotex Corp. has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report