Why it was recalled
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Product description
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 numbers, UPCs & expiration codes
Lot # TY9494, Exp Date: 05/31/2027.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0804-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 13, 2026
- FDA report date
- Sep 2, 2026
- Quantity
- 6,972 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0804-2026, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99673
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot # TY9494, Exp Date: 05/31/2027.
- Postal code
- 33326-3253
- Report date
- Sep 2, 2026
- Product type
- Drugs
- Recall number
- D-0804-2026
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 6,972 bottles
- Reason for recall
- Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Aug 13, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 27, 2026