Nitrofurantoin Oral Suspension — Class II drug recall D-0346-2019
Terminated recall by LUPIN SOMERSET, reported 2019-01-09, distributed nationwide. Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results f
| Recall number | D-0346-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUPIN SOMERSET, Somerset, NJ, United States |
| Recall initiated | 2018-12-21 |
| Classified | 2018-12-31 |
| Reported by FDA | 2019-01-09 |
| Terminated | 2023-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 23,460 bottles |
| Reason classes | potency |
| NDC | 43386-0450, 43386-0450-11 |
| Lot numbers | S700038, S700044, S700059, S700065, S700410, S700427, S700617, S700619, S700813, S700815, S700869, S700871, S700873, S700875, S701073 |
| Expiration dates | 2019-02-28, 2019-06-30, 2019-08-31, 2019-10-31, 2019-11-30, 2019-12-31 |
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, NDC 43386-450-11.
Reason for recall
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
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-0346-2019. 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.