openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 3
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
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.
Code information
Lot# 510122B; exp 04/13
Distribution pattern
US Nationwide and Puerto Rico
drug · product 2 of 3
Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
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.
Code information
Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
Distribution pattern
US Nationwide and Puerto Rico
drug · product 3 of 3
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
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Chemical contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
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.
