Fluoxetine Capsules USP — Class III drug recall D-0291-2015
Terminated recall by Sandoz Incorporated, reported 2014-12-17, distributed in AZ. Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo
| Recall number | D-0291-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Incorporated, Broomfield, CO, United States |
| Recall initiated | 2014-12-05 |
| Classified | 2014-12-09 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-06-24 |
| Distributed | AZ |
| Quantity | 1,008 bottles |
| Reason classes | labeling |
| NDC | 00781-2822-01 |
| Lot numbers | 10/17, ET5122 |
Product
Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
Reason for recall
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
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-0291-2015. 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.