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Verified · FDAClass II — Possible RiskMedications

0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose Recall 2026

SODIUM CHLORIDEIssued April 2, 2026Updated Reviewed by the Recall Watch editorial team

SODIUM CHLORIDE 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, — recalled per FDA on 4/2/2026. Reason: Lack of Assurance of Sterility.

Agency
FDA
Issued
Apr 2, 2026
Brand
SODIUM CHLORIDE
Distribution
1 states
Lots affected
1
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued April 2, 2026 · Last synced Nov 1, 2026

What's recalled

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.

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Why it was recalled

Lack of Assurance of Sterility

Affected products & lot numbers
1 lot called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
All lots within expiry
Where was it sold
1 state

USA Nationwide.

nationwide
Official noticefda.gov
More recalls like this
8 related — by brand, contaminant, and category

Frequently asked questions

Is the SODIUM CHLORIDE recall still active?

Yes, this recall is currently active as of April 2, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: All lots within expiry. Check the label on your product.

What should I do if I have the recalled SODIUM CHLORIDE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.