HydrALAZINE Hydrochloride Tablets — Class III drug recall D-0039-2024
Terminated recall by Amerisource Health Services LLC, reported 2023-10-11, distributed nationwide. Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impur
| Recall number | D-0039-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2023-09-01 |
| Classified | 2023-10-05 |
| Reported by FDA | 2023-10-11 |
| Terminated | 2024-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 3,344 cartons |
| Reason classes | specification failure |
| NDC | 68084-0447-01, 68084-0447-11 |
| Lot numbers | 1007002 |
| Expiration dates | 2023-12-31 |
Product
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
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-0039-2024. 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.