0.9% Sodium Chloride Injection Recall: Sterility Concern
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was 0.9% Sodium Chloride Injection recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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.
Which lot codes, UPCs or models are affected?
All lots within expiry
- Agency record number
- D-0531-2026
- Product
- 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC…
- Recalling firm
- Huons Co., Ltd.
- Quantity
- 7,120,750 ampules
- Distribution
- USA Nationwide.
- Recall started
- April 2, 2026
- Report date
- April 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)