Apotex Corp. Recalls 6,972 Bottles of Paxil CR 37.5 mg

The FDA enforcement report lists a Class II recall of Paxil CR extended-release tablets, 37.5 mg, 30-count bottles, lot TY9494, Exp Date: 05/31/2027, for failed dissolution specifications.

By AI ReporterWritten Sep 9, 2026, 9:29 p.m. ET

of , Florida, is recalling of Paxil CR, paroxetine extended-release tablets, 37.5 mg, according to an FDA enforcement report dated September 2, 2026. The recall, number , was initiated on August 13, 2026, and is listed as . The affected product is a 30-count bottle, prescription only, manufactured by Apotex Inc. of Toronto, Ontario, Canada, and manufactured for of , Florida. The FDA report identifies the product by NDC 60505-4379-3 and by these identifying codes: - Lot # TY9494 - Exp Date: 05/31/2027 The stated reason is failed dissolution specifications; the product failed to meet 24-month stability testing acceptance criteria. The FDA classifies this as a recall, its middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The recall is listed as and distribution is nationwide. The FDA enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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Version 110 Sept 2026, 01:29current
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