Huons Co. 10mL Sodium Chloride Injection Recall: Lack of Sterility Assurance
Huons Co. recalls 10mL sodium chloride injection ampules due to lack of sterility assurance. This may cause infections if used improperly. Affected lots are all within expiry dates.
Lower-risk recall
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Huons Co. is recalling 10mL sodium chloride injection ampules because they lack sterility assurance. This could lead to infections if the product is used without proper sterilization. Read more at govinfonow.com/recall/31367-huons-co-10ml-sodium-chloride-injection-recall-lack-of-sterility.
Source Summary by GovInfoNow · govinfonow.com/recall/31367-huons-co-10ml-sodium-chloride-injection-recall-lack-of-sterility · Updated August 17, 2026 · FDA enforcement record: FDA #D-0531-2026
Cite this page
“Huons Co. 10mL Sodium Chloride Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31367-huons-co-10ml-sodium-chloride-injection-recall-lack-of-sterility. Based on FDA recall #D-0531-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0531-2026%22&limit=1).
Why it’s dangerous
The product lacks sterility assurance, meaning it could be contaminated with bacteria. If used without proper sterilization, this could lead to infections in patients.
Who’s affected
Prescription patients who received this specific injection product. Healthcare providers using the product for medical treatments may also be affected.
How to tell if you have this one
Check for the product name: 0.9% Sodium Chloride Injection, USP, 10 mL Ampules. The product is prescription-only and manufactured for Spectra Medical Devices, LLC. All lots within expiry dates are affected.
- Brand
Huons Co.- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
USA Nationwide.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0529-2026 | 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); All lots within expiry | 33,599,925 ampules and 23658125 vials | 73293-0004-1, 73293-0004-2, 73293-0005-1, 73293-0005-2, 73293-0001-1, 73293-0001-2, 73293-0003-1, 73293-0003-2, 63739-170-13, 63739-170-24, 63739-170-27, 71351-026-20, 71351-026-25, 71351-027-20, 71351-027-25, 71351-021-05, 71351-021-10, 71351-021-25, 71351-023-05, 71351-023-10, 71351-023-25, 84769-0001-1, 84769-0001-2, 84769-0002-1, 84769-0002-2 |
| D-0530-2026 | 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); All lots within expiry | 3,260,170 ampules | 73293-0002-1, 73293-0002-2, 71351-022-02, 71351-022-50, 71351-022-10 |
| D-0531-2026 | 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.; All lots within expiry | 7,120,750 ampules | 65282-1510-1, 65282-1505-1 |
| D-0532-2026 | Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton); All lots within expiry | N/A | 73293-0004-1, 73293-0004-2, 73293-0005-1, 73293-0005-2, 73293-0001-1, 73293-0001-2, 73293-0003-1, 73293-0003-2, 71351-026-20, 71351-026-25, 71351-027-20, 71351-027-25, 71351-021-05, 71351-021-10, 71351-021-25, 71351-023-05, 71351-023-10, 71351-023-25, 68094-081-01, 68094-081-25, 84769-0001-1, 84769-0001-2, 84769-0002-1, 84769-0002-2 |
What to do — step by step
Check Product Details
Look for the product name and manufacturer information on the ampule label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0531-2026 (April 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0531-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.