# FDA recall D-0970-2015

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2015-04-13.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0970-2015
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-13
- **Report date:** 2015-05-06
- **Termination date:** 2016-10-27

- **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-0970-2015

## Citation

> AI Analytics. FDA recall D-0970-2015. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0970-2015. Source: US FDA. Licensed CC0.

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