Class IIReported 2025-02-12

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

Recalled by SKY PACKAGING

Reason for Recall

Failed Impurities/Degradation Specifications

Recall Number

D-0220-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-01-24

Reported

2025-02-12

Distribution

Nationwide within the United States

Code Info

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.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.