Paroxetine Extended-Release Tablets USP — Class III drug recall D-0974-2017
Terminated recall by Lupin Pharmaceuticals Inc., reported 2017-07-19, distributed nationwide. Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term s
| Recall number | D-0974-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2017-06-22 |
| Classified | 2017-07-12 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2019-01-17 |
| Distributed | Nationwide (US) |
| Quantity | 12,480 bottles |
| Reason classes | specification failure |
| NDC | 68180-0645, 68180-0645-01, 68180-0645-02, 68180-0645-06, 68180-0646, 68180-0646-01, 68180-0646-02, 68180-0646-03, 68180-0646-06, 68180-0647, 68180-0647-01, 68180-0647-02, 68180-0647-03, 68180-0647-06 |
| Lot numbers | H605710, H605711, H605712, H702202, H702255 |
| Expiration dates | 2018-11-20, 2019-03-20 |
Product
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06
Reason for recall
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
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-0974-2017. 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.