Nitrofurantoin Capsules — Class III drug recall D-0257-2019
Terminated recall by Sandoz Inc, reported 2018-11-21, distributed nationwide. Cross Contamination with Other Products
| Recall number | D-0257-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2018-11-02 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 14,366 bottles |
| NDC | 00185-0122, 00185-0122-01, 00185-0122-10 |
| Expiration dates | 2020-03 |
Product
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
Reason for recall
Cross Contamination with Other Products
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-0257-2019. 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.