Recalls / Class II
Class IID-0168-2025
Product
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.
- Affected lot / code info
- Lot # 47101; Exp. 02/2026
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 1016 50-count cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2024-12-04
- FDA classified
- 2024-12-31
- Posted by FDA
- 2025-01-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0168-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.