Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30… was recalled on August 13, 2026 in cooperation with the U.S. Food and Drug Administration because failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria.
Paxil CR, 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 60505-4379-3
Lot # TY9494, Exp Date: 05/31/2027.
Units affected: 6,972 bottles
Where it was sold: US Nationwide.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Apotex Corp.
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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