AvKARE recalls 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, 3x…

Recall date

September 2, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0007-2026

FDA classification

Class II

Brand / firm

AvKARE

Sold / distributed

U.S. Nationwide

Why it was recalled

Failed Content Uniformity Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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