FDA Drug recall D-0974-2017
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class III recall of Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0974-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-06-22 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Identifiers
| ndc | 68180-647-06 |
|---|---|
| ndc | 68180-647-01 |
| ndc | 68180-647-02 |
| ndc | 68180-647-03 |
| ndc | 68180-646-06 |
| ndc | 68180-646-01 |
| ndc | 68180-646-02 |
| ndc | 68180-646-03 |
| ndc | 68180-645-06 |
| ndc | 68180-645-01 |
| ndc | 68180-645-02 |
| code_info | Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0974-2017%22
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