FDA Drug recall D-0122-2024
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario,…
- FDA Drug
- Class II
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario,… by Apotex, citing failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0122-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-01 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
Product
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Reason
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Identifiers
| ndc | 60505-0097-1 |
|---|---|
| ndc | 60505-0097-9 |
| ndc | 60505-0097-2 |
| ndc | 60505-0097-4 |
| ndc | 60505-0097-7 |
| ndc | 60505-0097-5 |
| ndc | 60505-0083-1 |
| ndc | 60505-0083-9 |
| ndc | 60505-0083-2 |
| ndc | 60505-0083-4 |
| ndc | 60505-0083-0 |
| ndc | 60505-0083-5 |
| ndc | 60505-0084-1 |
| ndc | 60505-0084-9 |
| ndc | 60505-0084-2 |
| ndc | 60505-0084-4 |
| ndc | 60505-0084-5 |
| ndc | 60505-0101-1 |
| ndc | 60505-0101-9 |
| ndc | 60505-0101-2 |
| ndc | 60505-0101-4 |
| ndc | 60505-0101-5 |
| ndc | 60505-0101-7 |
| code_info | Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024 |
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 - 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 · 2026-09-02 · 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
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0122-2024%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.