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Verified · FDAClass II — Possible RiskMedications

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP ampules Recall 2026

BUPIVACAINE HYDROCHLORIDEIssued April 2, 2026Updated Reviewed by the Recall Watch editorial team

BUPIVACAINE HYDROCHLORIDE 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 — recalled per FDA on 4/2/2026. Reason: Lack of Assurance of Sterility.

Agency
FDA
Issued
Apr 2, 2026
Brand
BUPIVACAINE HYDROCHLORIDE
Distribution
1 states
Lots affected
1
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued April 2, 2026 · Last synced Nov 1, 2026

What's recalled

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)

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Why it was recalled

Lack of Assurance of Sterility

Affected products & lot numbers
1 lot called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
All lots within expiry
Where was it sold
1 state

USA Nationwide.

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the BUPIVACAINE HYDROCHLORIDE recall still active?

Yes, this recall is currently active as of April 2, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: All lots within expiry. Check the label on your product.

What should I do if I have the recalled BUPIVACAINE HYDROCHLORIDE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.