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Verified · FDAClass II — Possible RiskMedications

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL 1,000 mL in a Single Recall 2026

SODIUM CHLORIDEIssued March 11, 2026Updated Reviewed by the Recall Watch editorial team

SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical C — recalled per FDA on 3/11/2026. Reason: Lack of Assurance of Sterility.

Agency
FDA
Issued
Mar 11, 2026
Brand
SODIUM CHLORIDE
Distribution
1 states
Lots affected
16
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.

Verified summary of the official U.S. Food and Drug Administration notice · Issued March 11, 2026 · Last synced Nov 1, 2026

What's recalled

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.

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Why it was recalled

Lack of Assurance of Sterility

Affected products & lot numbers
16 lots called out

Affected Lot Numbers

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

Lot Number
Batch# 23SU10001
Exp Date: 12/31/2026
Batch# 24AU10003
24AU10004
24AU10005
24AU10008
Exp Date: 01/31/2027
Batch # 24EU10001
24EU10002
Exp Date: 05/31/2027
Batch# 24PU10002
Exp Date: 11/30/2027
Batch# 25BU10003
Exp Date: 02/29/2028
Batch# 25EU10005
Exp Date: 05/31/2028.
Where was it sold
1 state

US Nationwide , Alaska, and Puerto Rico.

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 March 11, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Batch# 23SU10001, Exp Date: 12/31/2026, Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027, Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027, Batch# 24PU10002, Exp Date: 11/30/2027, Batch# 25BU10003, Exp Date: 02/29/2028, Batch# 25EU10005, Exp Date: 05/31/2028.. 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.