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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SKY Packaging HydrALAZINE Hydrochloride Recalled for Impurities

Agency Publication Date: February 4, 2025
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Summary

SKY Packaging is voluntarily recalling HydrALAZINE Hydrochloride (25 mg and 50 mg) unit dose tablets, which are used to treat high blood pressure. The recall was initiated because the tablets failed to meet quality specifications for impurities and degradation during testing. Consumers who have these tablets should contact their healthcare provider or pharmacist and should not continue use without a suitable replacement.

Risk

Taking medication that has degraded or contains impurities may lead to the treatment being less effective at controlling blood pressure or potentially expose patients to harmful chemical byproducts. To date, no specific injuries or adverse events have been reported regarding these affected lots.

What You Should Do

  1. This recall involves HydrALAZINE Hydrochloride USP unit dose tablets in 25 mg (NDC 63739-327-10) and 50 mg (NDC 63739-328-10) strengths distributed by McKesson dba SKY Packaging.
  2. Identify the 25 mg tablets by checking for lot numbers 0000127312 (Exp. 3/31/2025), 0000127576 or 0000127577 (Exp. 7/31/2025), 0000128204 (Exp. 12/31/2025), or 0000128358 (Exp. 1/31/2026).
  3. Identify the 50 mg tablets by checking for lot numbers 0000127410 (Exp. 4/30/2025), 0000127579 (Exp. 8/31/2025), 0000128245 (Exp. 12/31/2025), or 0000128486 (Exp. 2/28/2026).
  4. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: HydrALAZINE Hydrochloride USP (25 mg)
Variants: 25 mg, 100 Unit Dose Tablets (10x10)
Lot Numbers:
0000127312 (Exp. 31-Mar-2025)
0000127576 (Exp. 31-Jul-2025)
0000127577 (Exp. 31-Jul-2025)
0000128204 (Exp. 31-Dec-2025)
0000128358 (Exp. 31-Jan-2026)
NDC:
63739-327-10

Manufactured by Strides Pharma Science Ltd, Bengaluru, India

Product: HydrALAZINE Hydrochloride USP (50 mg)
Variants: 50 mg, 100 Unit Dose Tablets (10x10)
Lot Numbers:
0000127410 (Exp. 30-Apr-2025)
0000127579 (Exp. 31-Aug-2025)
0000128245 (Exp. 31-Dec-2025)
0000128486 (Exp. 28-Feb-2026)
NDC:
63739-328-10

Manufactured by Strides Pharma Science Ltd, Bengaluru, India

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96159
Status: Active
Manufacturer: SKY PACKAGING
Sold By: McKesson; SKY Packaging
Manufactured In: India
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.