FDA recall, , Moderate risk
Huons Lidocaine, Bupivacaine and Sodium Chloride Injections
Lidocaine HCl injection lacks assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Huons Co., Ltd., of Jecheon, Korea, recalled multiple injectable products due to a lack of assurance of sterility. The recall began April 2, 2026, and was added to the FDA's Enforcement Report on April 14, 2026. The products were distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
4 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
An NDC (National Drug Code) is usually printed on the drug's label.
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (
- Strength
- 15 mg
- NDC
- 73293-0002-1
- 73293-0002-2
- 71351-022-02
- 71351-022-10
- 71351-022-50
- Lot code
- All lots within expiry
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free
- NDC
- 65282-1510-1
- Lot code
- All lots within expiry
Lidocaine HCl injection, USP, 1%
- Strength
- 50 mg
- NDC
- 73293-0001-1
- 73293-0001-2
- 63739-170-13
- 63739-170-24
- 63739-170-27
- 71351-021-05
- 71351-021-10
- 71351-021-25
- 84769-0001-1
- 84769-0001-2
- Lot code
- All lots within expiry
Lidocaine HCl Injection, USP, 2%
- Strength
- 100 mg
- NDC
- 73293-0003-1
- 73293-0003-2
- 71351-023-05
- 71351-023-10
- 71351-023-25
- 68094-081-01
- 68094-081-25
- 84769-0002-1
- 84769-0002-2
- Lot code
- All lots within expiry
Recall details
- Company began the recall
- Sold in
USA Nationwide.
- Company
- Huons Co., Ltd.Jecheon, Korea (the Republic of)
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98724
- Recall numbers
- D-0529-2026 to D-0532-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Listed on Recall Canary
Classified by FDA
Summary updated
