Nitrofurantoin Capsules USP — Class II drug recall D-0232-2021
Terminated recall by American Health Packaging, reported 2021-01-27, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0232-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2021-01-07 |
| Classified | 2021-01-15 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2022-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 1,948 cartons |
| Reason classes | specification failure |
| NDC | 68084-0446-01 |
| Lot numbers | 193757 |
| Expiration dates | 2022-01-31 |
Product
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
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-0232-2021. 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.