FDA Drug recall D-0257-2019
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01)
- FDA Drug
- Class III
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class III recall of Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01) by Sandoz, citing cross Contamination with Other Products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0257-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-11-02 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | US |
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
Cross Contamination with Other Products
Identifiers
| ndc | 0185-0122-01 |
|---|---|
| ndc | 0185-0122-10 |
| code_info | Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020 |
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-0257-2019%22
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