FDA Drug recall D-0877-2026
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
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manu… by Apotex, citing failed dissolution specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0877-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-23 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Apotex |
| Distribution | US |
Product
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 60505-1318-3
Reason
Failed dissolution specifications.
Identifiers
| ndc | 60505-1316-3 |
|---|---|
| ndc | 60505-1317-3 |
| ndc | 60505-1318-3 |
| ndc | 60505-3673-3 |
| ndc | 60505-3674-3 |
| ndc | 60505-3675-3 |
| code_info | Lot# TY9495, Exp Date: 05/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Apotex
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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
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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-0877-2026%22
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