Why it was recalled
Failed Content Uniformity Specifications
Product description
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 numbers, UPCs & expiration codes
Lot # LF41138A; Exp 06/30/2027
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0007-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 2, 2025
- FDA report date
- Oct 15, 2025
- Quantity
- 2192 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0007-2026, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 97542
- Address
- 615 N 1st St
- Code information
- Lot # LF41138A; Exp 06/30/2027
- Postal code
- 38478-2403
- Report date
- Oct 15, 2025
- Product type
- Drugs
- Recall number
- D-0007-2026
- Classification
- Class II
- Recalling firm
- AvKARE
- Product quantity
- 2192 cartons
- Reason for recall
- Failed Content Uniformity Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Sep 2, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 6, 2025