Recalls / Class II
Class IID-0007-2026
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
- Brand name
- Norgestimate And Ethinyl Estradiol
- Generic name
- Norgestimate And Ethinyl Estradiol
- NDC
- 42291-565
- FDA application
- ANDA091232
- Affected lot / code info
- Lot # LF41138A; Exp 06/30/2027
Why it was recalled
Failed Content Uniformity Specifications
Recalling firm
- Firm
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 2192 cartons
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-09-02
- FDA classified
- 2025-10-06
- Posted by FDA
- 2025-10-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0007-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.