Why it was recalled
Lack of Assurance of Sterility
Product description
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
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-0529-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 2, 2026
- FDA report date
- Apr 22, 2026
- Quantity
- 33,599,925 ampules and 23658125 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Huons Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-0529-2026, 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-0529-2026
- Classification
- Class II
- Recalling firm
- Huons Co., Ltd.
- Product quantity
- 33,599,925 ampules and 23658125 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- Apr 2, 2026
- Center classification date
- May 15, 2026