Huons Co., Ltd. recalls Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured
Recalled April 22, 2026 · FDA recall D-0530-2026 · Huons
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
3,260,170 ampules
Sold at
USA Nationwide.
Description
Lack of Assurance of Sterility
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)
Manufacturer(s)
Huons Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →