Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Femtrace 0.9 mg (Estradiol Acetate) Tablets Recalled by Warner Chilcott Company LLC Due to Failed Impurity/Degradation Specifications due to moisture ingress in...

Date: December 21, 2012
Company: Warner Chilcott Company LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Warner Chilcott Company LLC directly.

Affected Products

Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738

Quantity: 5439 bottles

Why Was This Recalled?

Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Warner Chilcott Company LLC

Warner Chilcott Company LLC has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report