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Huons Co: Multiple Rx Only Products
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DRUG RECALLMODERATE

Huons Co: Multiple Rx Only Products

Huons recalls Lidocaine HCl 1% vials and other injectables over sterility concerns.

What to do

Consumers should immediately stop using the recalled products, quarantine any remaining inventory, and contact McKesson Corporation dba Sky Packaging for return and replacement instructions.

Posted
Updated
Recall No.
D-0529-2026
Agency
Firm
Huons Co., Ltd.
Recall ID
98724
Status
ONGOING

Why it was recalled

Huons Co., Ltd. is recalling Lidocaine HCl Injection, USP, 1% 50mg/5mL (10 mg/mL) 5 mL Single Dose Vials, along with several other injectable products (0.9% Sodium Chloride Injection, Bupivacaine Hydrochloride in Dextrose Injection, and Lidocaine HCl Injection 2%), due to a lack of assurance of sterility. The products were distributed by McKesson Corporation dba Sky Packaging.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

ProductStrengthNDC / UPCRecall #
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.N/A
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)D-0530-2026
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.D-0531-2026
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, ChuD-0529-2026
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081D-0532-2026
Lidocaine HCl injection, USP, 1%50 mgNDC 73293-0001-1, NDC 73293-0001-2, NDC 63739-170-13, NDC 63739-170-24, NDC 63739-170-27, NDC 71351-021-05, NDC 71351-021-10, NDC 71351-021-25, NDC 84769-0001-1, NDC 84769-0001-2
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mgNDC 73293-0002-1, NDC 73293-0002-2, NDC 71351-022-02, NDC 71351-022-10, NDC 71351-022-50
Lidocaine HCl Injection, USP, 2%100 mgNDC 73293-0003-1, NDC 73293-0003-2, NDC 71351-023-05, NDC 71351-023-10, NDC 71351-023-25, NDC 68094-081-01, NDC 68094-081-25, NDC 84769-0002-1, NDC 84769-0002-2

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification