Recall
FDAHealthJanuary 24, 2025

SKY PACKAGING — HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba S

⚠️ Failed Impurities/Degradation Specifications

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
January 24, 2025

Nationwide within the United States

What's affected?

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
Lot code
0000127410

Additional details

Lot #: 0000127410, 63739-328-10, Exp. Date 30-Apr-2025; 0000127579, Exp. Date 31-Aug-2025; 0000128245, Exp. Date 31-Dec-2025; 0000128486, Exp. Date 28-Feb-2026.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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