FDAFDA · Food and drugs·Recall number D-0804-2026
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
Published September 2, 2026 · Recall initiated: August 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PAXIL
- Manufacturer
- Apotex Corp.
- Distributor
- US Nationwide.
- UPC
- 0360505366835
- Lot
- Lot # TY9494, Exp Date: 05/31/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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