D-0804-2026 Class II Ongoing
FDA drug recall D-0804-2026 was initiated by Apotex Corp. on August 13, 2026 and is designated Class II. Reason for recall: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria The recall status is ongoing. Affected quantity: 6,972 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2026
- Initiation Date
- August 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,972 bottles
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
Reason for Recall
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Distribution Pattern
US Nationwide.
Code Information
Lot # TY9494, Exp Date: 05/31/2027.