⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Huons Co., Ltd.: 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,

DrugsSource: FDA (drug) · Date: 2026-04-22

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Huons Co., Ltd.
Product
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)
Reason / hazard
Lack of Assurance of Sterility
Classification
Class II
Status
Ongoing
Distribution / sold at
USA Nationwide.
Recall initiated
2026-04-02
Code info
All lots within expiry
Product quantity
3,260,170 ampules
Voluntary mandated
Voluntary: Firm initiated
City
Jecheon
State
N/A
Country
Korea (the Republic of)
Event id
98724
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