FDA Drug recall D-0804-2026
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9… by Apotex, citing failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0804-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-13 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
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
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Identifiers
| ndc | 60505-4377-3 |
|---|---|
| ndc | 60505-4378-3 |
| ndc | 60505-4379-3 |
| ndc | 60505-3668-3 |
| ndc | 60505-3669-3 |
| ndc | 60505-3670-3 |
| code_info | Lot # TY9494, Exp Date: 05/31/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Apotex
- Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manu…
FDA Drug · Class II · 2026-10-07 · Apotex - Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg…
FDA Drug · Class II · 2026-04-22 · Apotex - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp
FDA Drug · Class II · 2026-03-25 · Apotex - Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C…
FDA Drug · Class II · 2025-10-08 · Apotex - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc.,…
FDA Drug · Class II · 2025-10-08 · Apotex
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0804-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.