Fluoxetine Capsules USP — Class II drug recall D-1280-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2014-05-07, distributed nationwide. Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
| Recall number | D-1280-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2014-02-12 |
| Classified | 2014-04-28 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2014-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 257,904 bottles |
| Reason classes | chemical contamination |
| NDC | 50111-0647, 50111-0647-01, 50111-0647-02, 50111-0647-03, 50111-0648, 50111-0648-01, 50111-0648-02, 50111-0648-03, 50111-0648-44 |
Product
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Reason for recall
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
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-1280-2014. 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.