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Class II · ModerateActive recall

Lidocaine Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberAll lots within expiry
Where it was soldUSA Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHuons Co, Ltd, Chungcheongbuk-do, Korea foreign manufacturer
Brand nameLIDOCAINE HYDROCHLORIDE
Generic nameLIDOCAINE HYDROCHLORIDE
Active ingredient(s)LIDOCAINE HYDROCHLORIDE
Distributed by / forMcKesson Corporation, dba Sky Packaging
NDC73293-0001-1
Show the full FDA record
Full product labelLidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
Recalling firmHuons Co., Ltd.
DistributionUSA Nationwide.
Quantity33,599,925 ampules and 23658125 vials
Recall initiated2026-04-02
Report date2026-04-22
Recall completed—
Recall numberD-0529-2026
ClassificationClass II
FDA statusOngoing
Origin on fileJecheon N/A Korea (the Republic of)

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.