# FDA recall D-305-2013

> **Warner Chilcott Company LLC** · Class III · drug recall initiated 2013-02-15.

## Product

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866

## Reason for recall

Chemical contamination: Firm's inspection discovered the  presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.

## Distribution

US Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-305-2013
- **Recalling firm:** Warner Chilcott Company LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-15
- **Report date:** 2013-05-08
- **Termination date:** 2014-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fajardo, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-305-2013

## Citation

> AI Analytics. FDA recall D-305-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-305-2013. Source: US FDA. Licensed CC0.

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