Official recall notice

FDA DrugClass IINotable

Bupivacaine Hydrochloride 0.75% Recall (Apr 2026) – Huons

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)

Recall date
2026-04-22
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Lack of Assurance of Sterility

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Product description

Lack of Assurance of Sterility

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