AvKARE recalls norgestimate and ethinyl estradiol tablets because they failed content uniformity specifications
The notice says these norgestimate and ethinyl estradiol tablets failed content uniformity specifications, and it covers 2192 cartons sold across the U.S.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- AvKARE
- Hazard
- Failed Content Uniformity Specifications
- Units
- 2192 cartons
- Where sold
- U.S. Nationwide
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 6, 2025
- Recall started
- September 2, 2025
- FDA enforcement report
- October 15, 2025
- Identifiers
- Codes: Lot # LF41138A; Exp 06/30/2027
- FDA recall number: D-0007-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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
- Reason for recall
- Failed Content Uniformity Specifications
- Classification
- Class II (Ongoing)
- Distribution
- U.S. Nationwide
- Quantity
- 2192 cartons
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