Drug recall D-0804-2026

Class II Ongoing reported Sep 2, 2026

Product

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

Reason for recall

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

Lots and codes

Lot # TY9494, Exp Date: 05/31/2027.

Recall details

Recalling firm
Apotex Corp., Weston, FL
Quantity
6,972 bottles
Distribution
US Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
August 13, 2026

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