Why it was recalled
Lack of Assurance of Sterility
Product description
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)
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
USA Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0530-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 2, 2026
- FDA report date
- Apr 22, 2026
- Quantity
- 3,260,170 ampules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Huons Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-0530-2026, exactly as published.
Show all FDA fields
- City
- Jecheon
- Status
- Ongoing
- Country
- Korea (the Republic of)
- Event ID
- 98724
- Address
- 100 Bio-Valley-Ro
- Code information
- All lots within expiry
- Report date
- Apr 22, 2026
- Product type
- Drugs
- Recall number
- D-0530-2026
- Classification
- Class II
- Recalling firm
- Huons Co., Ltd.
- Product quantity
- 3,260,170 ampules
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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)
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- Apr 2, 2026
- Center classification date
- May 15, 2026