FDAFDA recall D-0804-2026 · Sep 2, 2026
Apotex Corp.: Paxil CR recall
Recall found
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 for recall
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot # TY9494, Exp Date: 05/31/2027.
- Quantity
- 6,972 bottles
- Distribution
- US Nationwide.
- Recalling firm
- Apotex Corp., Weston, FL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-13
Source: openFDA enforcement record D-0804-2026 · search recall number D-0804-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.