Class IIDrug
Paxil CR recall
Summary
Apotex Corp. is recalling Paxil CR (drug). According to the FDA report, the reason is: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
- Lot / code info
- Lot # TY9494, Exp Date: 05/31/2027.
- Quantity
- 6,972 bottles
- Distribution
- US Nationwide.
- Recalling company
- Apotex Corp., Weston, FL United States
- Recall started
- August 13, 2026
- FDA report date
- September 2, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0804-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Apotex Corp.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.