FDA Drug recall D-0927-2018
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc
- FDA Drug
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc by Lupin Somerset, citing subpotent Drug and Failed Content Uniformity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0927-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-28 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Somerset |
| Distribution | US |
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
Subpotent Drug and Failed Content Uniformity.
Identifiers
| upc | 343386450114 |
|---|---|
| ndc | 43386-450-11 |
| code_info | Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0927-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.