Agency classClass IIOur severity:High FDA (Drugs)·D-0220-2025·Announced 2025-02-12

HydrALAZINE Hydrochloride tablets recalled for failed purity and degradation specifications

SKY PACKAGING is recalling HydrALAZINE Hydrochloride 50mg tablets nationwide due to failed impurities and degradation specifications. Four affected lot numbers have expiration dates from April 2025 to February 2026.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for failed drug purity and degradation specifications. No illnesses or injuries are reported in the source. Per the rubric, risk-of-harm products without reported injury warrant a maximum score of 3 (High).

Plain-English summary

HydrALAZINE Hydrochloride 50mg tablets are being recalled nationwide due to failed impurities and degradation specifications. The affected product was manufactured by Strides Pharma Science Ltd in Bengaluru, India, and distributed by SKY PACKAGING (McKesson Corporation) in Tennessee.

Four specific lot numbers are affected by this Class II recall, with expiration dates ranging from April 30, 2025 to February 28, 2026. The affected lot numbers are: 0000127410 (expires April 30, 2025), 0000127579 (expires August 31, 2025), 0000128245 (expires December 31, 2025), and 0000128486 (expires February 28, 2026). The product carries NDC 63739-328-10.

Patients with affected batches should contact their pharmacist or healthcare provider immediately for guidance.

The recalled product

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
Manufacturer: SKY PACKAGING
Category: Drug
Hazard: impurities
degradation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

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.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by SKY PACKAGING under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · SKY PACKAGING

See all →

High
Hydralazine Hydrochloride Tablets Recalled Due to Impurities and Degradation
FDA (Drugs) · 2025-02-12

Same hazard · impurities