Paroxetine Hydrochloride Tablets USP — Class II drug recall D-0119-2024
Ongoing recall by Apotex Corp., reported 2023-12-06, distributed nationwide. Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Gluc
| Recall number | D-0119-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2023-11-01 |
| Classified | 2023-11-27 |
| Reported by FDA | 2023-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 34,392 |
| Reason classes | specification failure |
| NDC | 60505-0083, 60505-0083-00, 60505-0083-01, 60505-0083-02, 60505-0083-04, 60505-0083-05, 60505-0083-09, 60505-0084, 60505-0084-01, 60505-0084-02, 60505-0084-04, 60505-0084-05, 60505-0084-09, 60505-0097, 60505-0097-01, 60505-0097-02, 60505-0097-04, 60505-0097-05, 60505-0097-07, 60505-0097-09, 60505-0101, 60505-0101-01, 60505-0101-02, 60505-0101-04, 60505-0101-05 and 2 more |
| Expiration dates | 2024-08 |
Product
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Reason for recall
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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-0119-2024. 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.