FDAFDA · Food and drugs·Recall number D-0530-2026
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)
Published April 22, 2026 · Recall initiated: April 2, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated
Recall details
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Huons Co., Ltd.
- Distributor
- USA Nationwide.
- UPC
- 0373293000218
- Lot
- All lots within expiry
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Korea (the Republic of)
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