FDA Drug recall D-305-2013
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured…
- FDA Drug
- Class III
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class III recall of 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, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-305-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-15 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Warner Chilcott |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot# 507694B; exp 02/13 |
|---|
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-305-2013%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.