FDA Drugs recall ·

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg… recall

Recall number
D-0007-2026
Date
(initiated September 2, 2025)
Company / brand
AvKARE
615 N 1st St, Pulaski, TN, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
2192 cartons
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28

Why was it recalled?

Failed Content Uniformity Specifications

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot # LF41138A; Exp 06/30/2027

Distribution

U.S. Nationwide

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0007-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.