The Recall Desk
ModerateFDA (Drugs)·D-303-2013·Announced 2013-05-08

Warner Chilcott Recalls Femhrt Tablets Due to Chemical Contamination

Warner Chilcott is recalling specific lots of Femhrt tablets because 2-phenylphenol was found in the product. The chemical migrated from the cardboard cartons used for packaging.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The hazard involves chemical contamination from packaging migration without reported injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Warner Chilcott Company LLC is recalling 27,509 bottles of Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count. The affected product is identified by Lot# 510122B and an expiration date of 04/13. The product was distributed nationwide in the United States and in Puerto Rico.

The recall was initiated after a firm inspection discovered the presence of 2-phenylphenol in the tablets. This chemical contamination resulted from the migration of the substance from the cardboard cartons in which the product was packaged.

Consumers who have this specific lot of Femhrt should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
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
Manufacturer
Warner Chilcott Company LLC
Category
Drug — Prescription Medication
Hazard
Affected units
27,509

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot# 510122B
  • exp 04/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Warner Chilcott Company LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Warner Chilcott Company LLC

See all →

Same hazard · chemical contamination

See all →