Voluntary Recall Issued for HydrALAZINE Hydrochloride Tablets Over Quality Defects

Strides Pharma Science Ltd has voluntarily recalled specific lots of HydrALAZINE Hydrochloride 25 mg tablets, distributed by McKesson Corporation under the name SKY Packaging, due to failed impurities and degradation specifications. The recall affects unit dose tablets of HydrALAZINE Hydrochloride, packaged in 10x10 unit dose packs, with the affected lot numbers including 0000127312 (expiring March 31, 2025), 0000127576, 0000127577 (both expiring July 31, 2025), 0000128204 (expiring December 31, 2025), and 0000128358 (expiring January 31, 2026). The product was manufactured in Bengaluru, India, and distributed nationwide within the US.

The recall has been classified as Class II by the US Food and Drug Administration (FDA), indicating that exposure to the affected product may cause temporary or medically reversible adverse health consequences, but the likelihood of serious harm is low. The recall was initiated voluntarily by the manufacturer on January 24, 2025, and is currently ongoing. The initial notification to consignees was made via telephone, and there has been no official press release issued regarding the recall.

HydrALAZINE Hydrochloride is an antihypertensive medication commonly used to manage high blood pressure by relaxing blood vessels, enabling smoother blood flow. Pharmacists should be aware of this recall and take appropriate action to remove the affected product from circulation to ensure patient safety.