Nitrofurantoin Oral Suspension USP — Class II drug recall D-0927-2018
Terminated recall by LUPIN SOMERSET, reported 2018-07-18, distributed nationwide. Subpotent Drug and Failed Content Uniformity.
| Recall number | D-0927-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUPIN SOMERSET, Somerset, NJ, United States |
| Recall initiated | 2018-06-28 |
| Classified | 2018-07-18 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2023-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 3,456 cartons |
| Reason classes | potency |
| NDC | 43386-0450, 43386-0450-11 |
| Lot numbers | 700619, S700065 |
| Expiration dates | 2019-02, 2019-08 |
Product
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11
Reason for recall
Subpotent Drug and Failed Content Uniformity.
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-0927-2018. 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.