Nitrofurantoin Capsules — Class II drug recall D-0168-2025
Ongoing recall by AvKARE, reported 2025-01-08, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0168-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2024-12-04 |
| Classified | 2024-12-31 |
| Reported by FDA | 2025-01-08 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 50268-0625-15 |
| Lot numbers | 47101 |
| Expiration dates | 2026-02 |
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.
Reason for recall
Failed Dissolution Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0168-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.