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Drug FDA Class II Ongoing Contamination / non-sterility

Lidocaine 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 63739-17

Huons Co., Ltd. Published Apr 22, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Huons Co., Ltd. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility

Hazards

Lack of Sterility Assurance · primary

Affected products (1)

Lidocaine 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)

LIDOCAINE HYDROCHLORIDE · 33,599,925 ampules and 23658125 vials

NDC: 73293-0001, 73293-0004, 73293-0005, 73293-0003, 63739-170, 71351-021, 71351-026, 71351-027, 71351-023, 84769-0001, 84769-0002, 73293-0004-1, 73293-0004-2, 73293-0005-1, 73293-0005-2, 73293-0001-1, 73293-0001-2, 73293-0003-1, 73293-0003-2, 63739-170-13, 63739-170-24, 63739-170-27, 71351-026-20, 71351-026-25, 71351-027-20, 71351-027-25, 71351-021-05, 71351-021-10, 71351-021-25, 71351-023-05, 71351-023-10, 71351-023-25, 84769-0001-1, 84769-0001-2, 84769-0002-1, 84769-0002-2
Lot codes: within
Code info: All lots within expiry

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 2, 2026
  2. Published
    Apr 22, 2026
Recall number
D-0529-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.