FDA Recall D-0220-2025
SKY PACKAGING · Memphis, TN
Class II Ongoing 475 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0220-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nationwide within the United States
- Recall initiated
- 2025-01-24
- Classified by FDA Center
- 2025-02-04
- FDA published
- 2025-02-12
- Recalling firm
- SKY PACKAGING
- Firm location
- Memphis, TN
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.