HydrALAZINE Hydrochloride — Class II drug recall D-0220-2025
Ongoing recall by SKY PACKAGING, reported 2025-02-12, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0220-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SKY PACKAGING, Memphis, TN, United States |
| Recall initiated | 2025-01-24 |
| Classified | 2025-02-04 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 63739-0328-10 |
| Lot numbers | 0000127410, 0000127579, 0000128245, 0000128486, 63739-328-10 |
| Expiration dates | 2025-04-30, 2025-08-31, 2025-12-31, 2026-02-28 |
Product
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
Reason for recall
Failed Impurities/Degradation 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-0220-2025. 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.