Recall
FDAHealthSeptember 2, 2025

AvKARE — 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,

⚠️ Failed Content Uniformity Specifications

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
September 2, 2025

U.S. Nationwide

What's affected?

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
Lot code
LF41138A

Additional details

Lot # LF41138A; Exp 06/30/2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2192 cartons.

View original FDA notice →

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