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Class II · ModerateActive recall

Paxil

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # TY9494, Exp Date: 05/31/2027.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byApotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326 foreign manufacturer
Brand namePAXIL
Generic namePAROXETINE HYDROCHLORIDE
Active ingredient(s)PAROXETINE HYDROCHLORIDE
Distributed by / forApotex Corp., Weston, Florida 33326
NDC60505-4379-3
Show the full FDA record
Full product labelPaxil 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
Recalling firmApotex Corp.
DistributionUS Nationwide.
Quantity6,972 bottles
Recall initiated2026-08-13
Report date2026-09-02
Recall completed—
Recall numberD-0804-2026
ClassificationClass II
FDA statusOngoing
Origin on fileWeston FL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.