CLASS II ONGOING Drug recall · Reported 12 Feb 2025 · FDA Enforcement Report

HydrALAZINE Hydrochloride recalled by Sky Packaging

SKY Packaging is recalling HydrALAZINE Hydrochloride , USP, distributed nationwide in the US. The recall was initiated on 24 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0219-2025
FDA event ID
96159
Recalling firm
SKY Packaging, Memphis, TN
Classification
Class II
Status
Ongoing
Recall initiated
24 Jan 2025
FDA classified
4 Feb 2025
Reported
12 Feb 2025
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Potency & Assay

Timeline

24 Jan 2025Recall initiated by company
4 Feb 2025Classified by FDA+11 days
12 Feb 2025Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications

Which lots are affected?

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

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96159

This product is part of a recall event; the main page for the event is HydrALAZINE Hydrochloride , USP, 50mg recalled by Sky Packaging.

ReportedClassRecallCompanyReasonWhere
CLASS IIHydrALAZINE Hydrochloride , USP, 50mg recalled by Sky PackagingSKY PackagingPotency & AssayNationwide

More recalls from SKY Packaging

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ReportedClassRecallCompanyReasonWhere
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Other Hydralazine recalls

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ReportedClassRecallCompanyReasonWhere
DrugCLASS IIHydrALAZINE Hydrochloride , USP, 50mg recalled by Sky PackagingSKY PackagingPotency & AssayNationwide
DrugCLASS IIIHydralazine HCl Tablets, USP, 25mg recalled by The Harvard Drug GroupThe Harvard Drug GroupPotency & AssayNationwide
DrugCLASS IIHydrALAZINE Hydrochloride Tablets, USP 10mg recalledThe Harvard Drug GroupPotency & AssayNationwide
DrugCLASS IIIHydrALAZINE Hydrochloride Tablets, USP, 10 mg (10 x per unit dose recalledAmerisource Health ServicesPotency & AssayNationwide
DrugCLASS IIHydrALAZINE Hydrochloride Tablets, USP, 25 mg recalledCardinal HealthcareManufacturing (CGMP) DeviationsNationwide