August 2026 FDA Recall Paxil by Apotex Corp.
D-0804-2026 - Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
This Class II drug recall was voluntarily initiated by Apotex Corp. on August 13, 2026 for the product Paxil. The FDA reported the reason for recall as failed dissolution specifications; product failed to meet 24-month stability testing acceptance criteria. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0804-2026
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
08-13-2026
09-02-2026
6,972 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# TY9494, Exp Date: 05/31/2027.
