FDA Drug recall D-0653-2022
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia,…
- FDA Drug
- Class II
- terminated
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia,… by The Harvard Drug Group, citing failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0653-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-24 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Identifiers
| code_info | Lot #: T03755, T03756, Exp. Date 03/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0653-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.