Why it was recalled
Failed Dissolution Specifications
Product description
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
Lot numbers, UPCs & expiration codes
Lot # 47101; Exp. 02/2026
Where it was sold
Nationwide USA
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-0168-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 4, 2024
- FDA report date
- Jan 8, 2025
- Quantity
- 1016 50-count cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0168-2025, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 95919
- Address
- 615 N 1st St
- Code information
- Lot # 47101; Exp. 02/2026
- Postal code
- 38478-2403
- Report date
- Jan 8, 2025
- Product type
- Drugs
- Recall number
- D-0168-2025
- Classification
- Class II
- Recalling firm
- AvKARE
- Product quantity
- 1016 50-count cartons
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Dec 4, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 31, 2024