CLASS III Drug recall · Reported 8 May 2013 · FDA Enforcement Report
Femhrt (norethindrone acetate recalled by Warner Chilcott Company
Warner Chilcott is recalling Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg bottle (, distributed nationwide in the US. The recall was initiated on 15 Feb 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-305-2013
- FDA event ID
- 64459
- Recalling firm
- Warner Chilcott, Fajardo, PR
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Feb 2013
- FDA classified
- 30 Apr 2013
- Reported
- 8 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 15 Feb 2013 | Recall initiated by company | |
| 30 Apr 2013 | Classified by FDA | +74 days |
| 8 May 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
US Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot# 507694B; exp 02/13
Where was it sold?
US Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 64459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Femhrt (norethindrone acetate recalled by Warner Chilcott Company | Warner Chilcott | Packaging Defects | Nationwide | |
| CLASS III | Jevantique (norethindrone acetate and ethinyl estradiol) tablets recalled | Warner Chilcott | Packaging Defects | Nationwide |
More recalls from Warner Chilcott
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Jevantique (norethindrone acetate and ethinyl estradiol) tablets recalled | Warner Chilcott | Packaging Defects | Nationwide |
| Drug | CLASS III | Femhrt (norethindrone acetate recalled by Warner Chilcott Company | Warner Chilcott | Packaging Defects | Nationwide |
| Drug | CLASS III | Femtrace 0.9 mg (Estradiol Acetate) Tablets recalled | Warner Chilcott | Potency & Assay | Nationwide |
| Drug | CLASS III | Femtrace 0.45 mg (Estradiol Acetate) Tablets recalled | Warner Chilcott | Potency & Assay | Nationwide |
Other Femhrt (norethindrone recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Femhrt (norethindrone acetate recalled by Warner Chilcott Company | Warner Chilcott | Packaging Defects | Nationwide |