Official recall notice

FDA DrugClass IINotable

Paroxetine Extended-Release Tablets Recall (Oct 2026) – Apotex

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

Recall date
2026-10-07
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Failed dissolution specifications.

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Product description

Failed dissolution specifications.

Affected products

Lot# TY9495, Exp Date: 05/2027.

Verify with the official notice →
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