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.
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