Paroxetine HCL Controlled-Release Tablets 12 — Class II drug recall D-1574-2014
Terminated recall by Apotex Inc., reported 2014-09-10, distributed nationwide. Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contamin
| Recall number | D-1574-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., Toronto, Canada |
| Recall initiated | 2014-03-24 |
| Classified | 2014-09-03 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2014-09-23 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination |
| NDC | 60505-3673-03 |
| Lot numbers | 01/15, 03/15, 06/15, 07/15, 2A001, 2A002, 2C003, 2F005, 2G006 |
Product
Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3
Reason for recall
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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-1574-2014. 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.