FDA Drug recall D-0097-2018
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2017-12-06
On 2017-12-06 the FDA classified a Class III recall of Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing failed Dissolution Specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0097-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-11-21 |
| Published | 2017-12-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
Reason
Failed Dissolution Specification
Identifiers
| upc | 368180295068 |
|---|---|
| ndc | 68180-294-07 |
| ndc | 68180-294-03 |
| ndc | 68180-294-09 |
| ndc | 68180-294-06 |
| ndc | 68180-295-06 |
| ndc | 68180-295-09 |
| ndc | 68180-295-03 |
| ndc | 68180-296-03 |
| ndc | 68180-296-06 |
| ndc | 68180-296-09 |
| ndc | 68180-297-06 |
| ndc | 68180-297-09 |
| ndc | 68180-297-03 |
| ndc | 3681802950 |
| code_info | Lot #: G602051, Exp. 12/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0097-2018%22
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