Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg...
FDA Recall #D-0007-2026 — Class II — September 2, 2025
Product Description
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
Reason for Recall
Failed Content Uniformity Specifications
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2192 cartons
Distribution
U.S. Nationwide
Code Information
Lot # LF41138A; Exp 06/30/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated