# FDA recall D-1280-2014

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2014-02-12.

## 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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1280-2014
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-02-12
- **Report date:** 2014-05-07
- **Termination date:** 2014-12-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1280-2014

## Citation

> AI Analytics. FDA recall D-1280-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1280-2014. Source: US FDA. Licensed CC0.

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