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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Huons Injectable Medications Recalled for Lack of Sterility

Agency Publication Date: April 14, 2026
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Summary

Huons Co., Ltd. is recalling over 43 million units of various injectable medications, including Lidocaine, Bupivacaine, and Sodium Chloride, because they may not be sterile. The recall affects approximately 33.6 million ampules and 23.6 million vials of Lidocaine, 3.2 million ampules of Bupivacaine, and 7.1 million ampules of Sodium Chloride. No injuries or infections have been reported to date, but the use of non-sterile injectable products can lead to serious or life-threatening infections.

Risk

The lack of sterility assurance means these injectable drugs could be contaminated with microorganisms. Injecting a non-sterile product directly into the body can cause severe infections, sepsis, and other life-threatening complications.

What You Should Do

  1. Check your supply for Lidocaine HCl (NDC 63739-170-13, 63739-170-24, 63739-170-27), Bupivacaine Hydrochloride (NDC 73293-0002-2, 73293-0002-1), or Sodium Chloride Injection (NDC 65282-1510-1).
  2. Identify affected products by checking the lot number and expiration date on the vial, ampule, or outer carton; all lots that have not yet expired are included in this recall.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL)
Variants: 5 mL Single Dose Vials, 10 count cartons, 25 count cartons
Lot Numbers:
All lots within expiry
NDC:
63739-170-13
63739-170-24
63739-170-27

Distributed by McKesson Corporation dba Sky Packaging; Manufactured by Huons Co, Ltd.

Product: Bupivacaine Hydrochloride in 8.25 Dextrose Injection, USP, 0.75% (15 mg/2 mL) (7.5 mg/mL)
Variants: 50 x 2 Single-dose ampules, 2 mL ampule, 50 mL ampule
Lot Numbers:
All lots within expiry
NDC:
73293-0002-2
73293-0002-1

Manufactured by Huons Co., Ltd.

Product: 0.9% Sodium Chloride Injection, USP, 10 mL Ampules
Variants: 10 mL Ampules, Single Dose, Preservative Free
Lot Numbers:
All lots within expiry
NDC:
65282-1510-1

Manufactured for Spectra Medical Devices, LLC by Huons Co., Ltd.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98724
Status: Active
Manufacturer: Huons Co., Ltd.
Sold By: McKesson Corporation; Sky Packaging; Spectra Medical Devices, LLC
Manufactured In: Korea (the Republic of)
Units Affected: 43,980,845
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.