Agency classClass IIOur severity:High FDA (Drugs)·D-0219-2025·Announced 2025-02-12

Hydralazine Hydrochloride Tablets Recalled Due to Impurities and Degradation

SKY Packaging recalls Hydralazine Hydrochloride 25 mg tablets nationwide due to failed quality specifications for impurities and degradation.

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: FDA Class II recall of prescription drug due to failed quality specifications for impurities and degradation. No illnesses or injuries reported. Quality specification failures represent risk-of-harm products, meeting the High severity criterion.

Plain-English summary

SKY Packaging is recalling specific lots of Hydralazine Hydrochloride 25 mg tablets. The affected product was manufactured by Strides Pharma Science Ltd in Bengaluru, India, and distributed nationwide in the United States. The affected lot numbers are 0000127312 (expiration date March 31, 2025), 0000127576 (expiration date July 31, 2025), 0000127577 (expiration date July 31, 2025), 0000128204 (expiration date December 31, 2025), and 0000128358 (expiration date January 31, 2026).

The recall was initiated because the tablets failed quality specifications for impurities and degradation. Hydralazine Hydrochloride is a prescription medication. The FDA classified this as a Class II recall.

Patients or anyone who may have received one of the affected lots should contact their pharmacy or healthcare provider to confirm whether they received the recalled medication. Healthcare providers and patients should discuss what steps to take, as patients should not discontinue their medication without medical guidance.

The recalled product

Product: HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
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 #: 0000127312
Exp. Date 31-Mar-2025
0000127576
0000127577
Exp. Date 31-Jul-2025
0000128204
Exp. Date 31-Dec-2025
0000128358
Exp. Date 31-Jan-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

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High
HydrALAZINE Hydrochloride tablets recalled for failed purity and degradation specifications
FDA (Drugs) · 2025-02-12

Same hazard · impurities