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Class II · ModerateActive recall

Bupivacaine Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberAll lots within expiry
Where it was soldUSA Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHouns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea foreign manufacturer
Brand nameBUPIVACAINE HYDROCHLORIDE
Generic nameBUPIVACAINE HYDROCHLORIDE
Active ingredient(s)BUPIVACAINE HYDROCHLORIDE
Distributed by / forHuons Co., Ltd.
NDC73293-0002-1
Show the full FDA record
Full product labelBupivacaine 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)
Recalling firmHuons Co., Ltd.
DistributionUSA Nationwide.
Quantity3,260,170 ampules
Recall initiated2026-04-02
Report date2026-04-22
Recall completed—
Recall numberD-0530-2026
ClassificationClass II
FDA statusOngoing
Origin on fileJecheon N/A Korea (the Republic of)

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.