Apotex Corp. recalls Paxil CR
- Recalling company
- Apotex Corp.
- 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
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 13, 2026
- Reported
- Sep 2, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- 6,972 bottles
- Lot / codes
- Lot # TY9494, Exp Date: 05/31/2027.
- Company location
- Weston, FL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0804-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0804-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.