Lower riskDrug recall · FDA · Published May 23, 2023
Fresenius Medical Care Sodium Chloride 0.9% Injection Recall: Potential Packaging Leaks
Fresenius Medical Care recalls 1000mL Sodium Chloride 0.9% Injection bags due to potential packaging leaks from temperature exposure. This may cause contamination risks. Check your NDC # 49230-300-10 and lot numbers.
“Fresenius Medical Care Sodium Chloride 0.9% Injection Recall: Potential Packaging Leaks.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33430-fresenius-medical-care-sodium-chloride-0-9-injection-recall-potential. Based on FDA recall #D-0777-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0777-2023%22&limit=1).
The FDA announced on May 23, 2023, that Fresenius Medical Care Holdings, Inc. is recalling Sodium Chloride 0.9% Injection, USP, due to a lack of sterility assurance. The agency stated the product may have been exposed to below-recommended storage temperatures, potentially causing packaging leaks.
How to tell if you have it
Brand: Fresenius Medical Care
Product: Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton
NDC: 49230-300-10
Lot codes: 23AU05030 (Exp 01/13/2024), 23AU05035 (Exp 01/15/2024)
Distribution: 32 clinics in SC, NC and VA
The hazard
The FDA said the product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. This lack of assurance of sterility poses a risk to patients using the injection.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since 2014-04-14. Recent brand recalls include a Bicarby Dialysate leak risk reported on 2026-05-12 and a 5008X Blood Tubing Set recall for online port errors on 2026-05-11. Other recent recalls of similar products include Fresenius Kabi 0.9% Sodium Chloride Injection Recall, Fresenius Kabi 1000mL Sodium Chloride Injection Recall, and Fresenius Kabi 500mL Sodium Chloride Injection Recall, all dated 2026-03-11.
How to tell if you have this one
Check for NDC # 49230-300-10, lot numbers 23AU05030 (expiring 01/13/2024) or 23AU05035 (expiring 01/15/2024). These bags are sold for prescription use only.
Brand
Fresenius Medical Care
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC # 49230-300-10 and lot numbers 23AU05030 or 23AU05035 on the packaging.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “Product was distributed to 32 clinics in SC, NC and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: North Carolina, South Carolina, Virginia.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0777-2023 (May 23, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0777-2023 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.