Class III โ€” Low Risk

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

Gildess FE 1.5/30 (norethindrone acetate Recalled by Par Pharmaceutical, Inc. Due to Subpotent Drug; Ethinyl Estradiol

Date: September 27, 2016
Company: Par Pharmaceutical, Inc.
Status: Completed
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 Par Pharmaceutical, Inc. directly.

Affected Products

Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Quantity: 278,406 tablets

Why Was This Recalled?

Subpotent Drug; Ethinyl Estradiol

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Par Pharmaceutical, Inc.

Par Pharmaceutical, Inc. has 8 total recalls tracked by RecallDetector.

Related Recalls

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