Official recall notice
FDA DrugClass IINotable
FDA Recall: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: A
- Recall date
- 2026-09-02
- Brand
- Apotex Corp.
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Product description
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Affected products
Lot # TY9494, Exp Date: 05/31/2027.