CLASS II ONGOING Drug recall · Reported 22 Apr 2026 · FDA Enforcement Report
0.9% Sodium Chloride Injection, USP Ampules recalled by Huons Co
Huons is recalling 0.9% Sodium Chloride Injection, USP Ampules, distributed nationwide in the US. The recall was initiated on 2 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0531-2026
- FDA event ID
- 98724
- Recalling firm
- Huons, Jecheon, N/A
- Brand
- Sodium Chloride
- Manufacturer
- Spectra Medical Deviecs, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Apr 2026
- FDA classified
- 15 May 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Apr 2026 | Recall initiated by company | |
| 22 Apr 2026 | Published in enforcement report | +20 days |
| 15 May 2026 | Classified by FDA | +23 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lots within expiry
Where was it sold?
USA Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 98724| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recalledBupivacaine Hydrochloride | Huons | Sterility | Nationwide | |
| CLASS II | Lidocaine HCl injection, USP, 1% 50mg/ (10 mg/mL) Single Dose Vials recalledLidocaine Hydrochloride | Huons | Sterility | Nationwide | |
| CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Huons CoLidocaine Hydrochloride | Huons | Sterility | Nationwide |
More recalls from Huons
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Huons CoLidocaine Hydrochloride | Huons | Sterility | Nationwide |
| Drug | CLASS II | Lidocaine HCl injection, USP, 1% 50mg/ (10 mg/mL) Single Dose Vials recalledLidocaine Hydrochloride | Huons | Sterility | Nationwide |
| Drug | CLASS II | Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recalledBupivacaine Hydrochloride | Huons | Sterility | Nationwide |
Other Sodium Chloride recalls
All 133| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS II | Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation | B Braun Medical | Sterility | Nationwide |