Nitrofurantoin Capsules — Class III drug recall D-0880-2022
Terminated recall by American Health Packaging, reported 2022-05-25, distributed nationwide. Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of th
| Recall number | D-0880-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2022-05-03 |
| Classified | 2022-05-18 |
| Reported by FDA | 2022-05-25 |
| Terminated | 2023-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,603 cartons |
| Reason classes | specification failure |
| NDC | 68084-0446-01, 68084-0446-11 |
| Lot numbers | 1003829 |
| Expiration dates | 2023-01-31 |
Product
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
Reason for recall
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
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-0880-2022. 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.