Nitrofurantoin Monohydrate/Macrycrystals Capsules — Class II drug recall D-1722-2019
Terminated recall by Alvogen, Inc, reported 2019-08-21, distributed in PR. Failed dissolution specifications
| Recall number | D-1722-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alvogen, Inc, Pine Brook, NJ, United States |
| Recall initiated | 2019-07-24 |
| Classified | 2019-08-12 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2021-08-04 |
| Distributed | PR |
| Quantity | 2,784 bottles |
| Reason classes | specification failure |
| NDC | 47781-0303, 47781-0303-01 |
| Lot numbers | 471976 |
| Expiration dates | 2020-03 |
Product
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
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-1722-2019. 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.