hydrALAZINE HCl Tablets — Class II drug recall D-0653-2022
Terminated recall by The Harvard Drug Group, reported 2022-03-23, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability te
| Recall number | D-0653-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2022-02-24 |
| Classified | 2022-03-14 |
| Reported by FDA | 2022-03-23 |
| Terminated | 2023-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 5,953 cartons |
| Reason classes | specification failure |
| NDC | 00904-6440-61 |
| Lot numbers | T03755, T03756 |
| Expiration dates | 2023-03 |
Product
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
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-0653-2022. 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.