FDA Drug recall D-1281-2014
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Po…
- FDA Drug
- Class II
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class II recall of Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Po… by Teva Pharmaceuticals Usa, citing chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1281-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-12 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
Reason
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Identifiers
| upc | 350111647015 |
|---|---|
| ndc | 50111-647-01 |
| ndc | 50111-647-02 |
| ndc | 50111-647-03 |
| ndc | 50111-648-01 |
| ndc | 50111-648-02 |
| ndc | 50111-648-03 |
| ndc | 50111-648-44 |
| code_info | Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15 |
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-1281-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.