Paxil CR — Class II drug recall D-0804-2026
Ongoing recall by Apotex Corp., reported 2026-09-02, distributed nationwide. Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
| Recall number | D-0804-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2026-08-13 |
| Classified | 2026-08-27 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 6,972 bottles |
| Reason classes | specification failure |
| NDC | 60505-4379-03 |
| Lot numbers | TY9494 |
| Expiration dates | 2027-05-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0804-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.