# FDA recall D-496-2013

> **Teva Pharmaceuticals USA, Inc.** · Class III · drug recall initiated 2013-03-14.

## Product

Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA  NDC 51285-058-66

## Reason for recall

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

## Distribution

Nationwide

## Key facts

- **Recall number:** D-496-2013
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-14
- **Report date:** 2013-06-05
- **Termination date:** 2014-01-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-496-2013

## Citation

> AI Analytics. FDA recall D-496-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-496-2013. Source: US FDA. Licensed CC0.

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