Lower risk Drug recall · FDA · Published April 28, 2021

Fresenius Medical Care Sodium Chloride 0.9% Recall: Temperature Abuse Hazard

Fresenius Medical Care recalls 1000mL Sodium Chloride 0.9% due to temperature abuse risk. Product may be exposed to unsafe temperatures, causing potential issues. Check NDC 46163-0300-10 and lot numbers for affected units.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0603-2021Drug Fresenius Medical Care ›

Lower-risk recall

Temperature Abuse: Product exposed to temperature outside specified limits.

Take action

Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521

✎ GovInfoNow plain-language explainer

Fresenius Medical Care is recalling 1000mL Sodium Chloride 0.9% solution because it can be exposed to temperatures outside the specified range. This could lead to improper solution stability or safety risks if the product is not stored correctly. Read more at govinfonow.com/recall/36169-fresenius-medical-care-sodium-chloride-0-9-recall-temperature-abuse.

Source Summary by GovInfoNow · govinfonow.com/recall/36169-fresenius-medical-care-sodium-chloride-0-9-recall-temperature-abuse · Updated October 4, 2026 · FDA enforcement record: FDA #D-0603-2021

Cite this page

“Fresenius Medical Care Sodium Chloride 0.9% Recall: Temperature Abuse Hazard.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36169-fresenius-medical-care-sodium-chloride-0-9-recall-temperature-abuse. Based on FDA recall #D-0603-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0603-2021%22&limit=1).

The FDA announced on April 28, 2021, that Fresenius Medical Care Holdings, Inc. voluntarily recalled Sodium Chloride 0.9%, USP, due to temperature abuse hazards. The recall affects specific lots distributed nationwide within the United States.

How to tell if you have it

Brand: Fresenius Medical Care
Product: Sodium Chloride 0.9%, USP, 1000 mL
NDC: 46163-0300-10
Lot #: 20NG02095
Exp. Date: October 2021
Manufacturer: Fresenius Medical Care North America, Waltham, MA 02451

The hazard

The product was exposed to temperatures outside specified limits, according to the FDA. This temperature abuse poses a potential risk to users of the affected Sodium Chloride solution.

Context

GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Recent brand recalls include Fresenius Bicarby Dialysate leaks reported on May 12, 2026, and Fresenius 5008X Blood Tubing Set errors reported on May 11, 2026. Other recent recalls of similar products include Fresenius Kabi 1000mL Sodium Chloride Injection (March 11, 2026), Fresenius Kabi 0.9% Sodium Chloride Injection (March 11, 2026), and Fresenius Kabi 500mL Sodium Chloride Injection (March 11, 2026).

How to tell if you have this one

Check for the NDC code 46163-0300-10 and lot number 20NG02095 on the product label. This product was manufactured by Fresenius Medical Care North America and sold with an expiration date of October 2021.

Brand
Fresenius Medical Care
Category
Drug

FDA recall event · 8 products

All 8 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.

Status
Terminated
Distribution
Nationwide within the United States

Recall number	Product, codes & lots	Quantity	Class	NDC
D-0603-2021	Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10; Lot #: 20NG02095, Exp. Date October 2021	48 cases	Class II	—
D-0604-2021	DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50; Lot #: 20JU01001, Exp. Date February 2022	25 cases	Class III	—
D-0605-2021	DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451; Lot #: a) 20PU03043, Exp. Date June 2022; b) 20SU03036, Exp. date July 2022; c) 20Su07012, Exp. date July 2022; 21AU07021, 21AU02037, 21AU01007, 21AU01006, 21AU01019, Exp. date August 2022	672 cases	Class III	49230-206-20, 49230-206-30, 49230-206-32, 49230-206-50, 49230-206-60, 49230-206-62, 49230-206-52, 49230-209-23, 49230-209-30, 49230-209-32, 49230-209-50, 49230-209-60, 49230-209-62, 49230-209-52, 49230-212-23, 49230-212-30, 49230-212-32, 49230-212-50, 49230-212-60, 49230-212-62, 49230-212-52, 49230-0209-23
D-0606-2021	DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50; Lot #: 21AK01022, Exp. date July 2022; 20SK01022, Exp. date June 2022	49 cases	Class III	—
D-0607-2021	DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92; Lot #: 20SU02032, Exp. date July 2022	5 cases	Class III	49230-206-92, 49230-206-94, 49230-206-95, 49230-209-92, 49230-209-94, 49230-209-95, 49230-212-92, 49230-212-94, 49230-212-95
D-0608-2021	DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,; Lot #: a) 20PU02010, Exp. date June 2022 and b) 20SU04033, Exp. date July 2022	39 cases	Class III	49230-206-92, 49230-206-94, 49230-206-95, 49230-209-92, 49230-209-94, 49230-209-95, 49230-212-92, 49230-212-94, 49230-212-95
D-0609-2021	DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92; Lot #: 20PU04030, Exp. date June 2022	4 cases	Class III	49230-206-92, 49230-206-94, 49230-206-95, 49230-209-92, 49230-209-94, 49230-209-95, 49230-212-92, 49230-212-94, 49230-212-95
D-0610-2021	DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451; Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022	285 cases	Class III	49230-206-20, 49230-206-30, 49230-206-32, 49230-206-50, 49230-206-60, 49230-206-62, 49230-206-52, 49230-209-23, 49230-209-30, 49230-209-32, 49230-209-50, 49230-209-60, 49230-209-62, 49230-209-52, 49230-212-23, 49230-212-30, 49230-212-32, 49230-212-50, 49230-212-60, 49230-212-62, 49230-212-52

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the NDC code 46163-0300-10 and lot number 20NG02095 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

Apr 28, 2021Firm started the recall
Jun 9, 2021FDA classified it Class II
Jun 16, 2021Published in FDA’s Enforcement Report
Sep 17, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Fresenius Medical Care recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36169-fresenius-medical-care-sodium-chloride-0-9-recall-temperature-abuse">Fresenius Medical Care Sodium Chloride 0.9% Recall: Temperature Abuse Hazard (GovInfoNow)</a>

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-0603-2021 (April 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0603-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.