FDA Drug recall D-0120-2024
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2
- 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, 20 mg, a) 100-count bottle, NDC#:60505-0083-2 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-0120-2024 |
| 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, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 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: a)100 count bottle: RV2384, RV2385; b) 1000 count bottle: RV2396, RV2397; 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.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0120-2024%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.