FDAFDA · Food and drugs·Recall number D-0007-2026
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
Published October 15, 2025 · Recall initiated: September 2, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Content Uniformity Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NORGESTIMATE AND ETHINYL ESTRADIOL
- Manufacturer
- AvKARE
- Distributor
- U.S. Nationwide
- Lot
- Lot # LF41138A; Exp 06/30/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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