Nitrofurantoin Oral Suspension — Class II drug recall D-1030-2016
Terminated recall by Nostrum Laboratories, Inc., reported 2016-06-22, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1030-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nostrum Laboratories, Inc., Bryan, OH, United States |
| Recall initiated | 2016-05-23 |
| Classified | 2016-06-14 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 2,839 bottles |
| Reason classes | specification failure |
| NDC | 57664-0239-32 |
| Expiration dates | 2017-02 |
Product
Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
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-1030-2016. 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.