Fluoxetine Capsules USP — Class II drug recall D-0970-2015
Terminated recall by Teva Pharmaceuticals USA, reported 2015-05-06, distributed nationwide. Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API th
| Recall number | D-0970-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2015-04-13 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2016-10-27 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, specification failure |
| 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 |
| Lot numbers | 6A207012 |
| Expiration dates | 2015-07 |
Product
Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01
Reason for recall
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
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-0970-2015. 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.