Lower riskDrug recall · FDA · Published November 15, 2018
Fresenius Kabi Recalls 0.9% Sodium Chloride Injection Vials Due to Latex Contamination
Fresenius Kabi recalls 0.9% sodium chloride injection vials with natural rubber latex in stoppers. Incorrect labeling may cause allergic reactions in sensitive users. Check product codes and lots for affected items.
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Take action
Contact the company
📍Recalling firmFresenius Kabi USA, LLC3159 Staley Rd · Grand Island, NY 14072-2028
✎ GovInfoNow plain-language explainer
Fresenius Kabi is recalling certain 0.9% sodium chloride injection vials because they contain natural rubber latex in the stoppers, contrary to the product labels. This could cause allergic reactions in people sensitive to latex, especially healthcare workers and patients receiving injections. Read more at govinfonow.com/recall/39429-fresenius-kabi-recalls-0-9-sodium-chloride-injection-vials-due.
“Fresenius Kabi Recalls 0.9% Sodium Chloride Injection Vials Due to Latex Contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39429-fresenius-kabi-recalls-0-9-sodium-chloride-injection-vials-due. Based on FDA recall #D-0299-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0299-2019%22&limit=1).
The FDA announced on 2018-11-15 that Fresenius Kabi USA, LLC is recalling Sodium Chloride Injection, USP, 0.9%, 20 mL Single Dose Vials due to labeling errors stating the stoppers do not contain natural rubber latex when they do. The recall affects product codes 918610 and 918620 distributed nationwide.
How to tell if you have it
Brand: Fresenius Kabi
Product: SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray
Distribution: Nationwide in the USA and Puerto Rico
The hazard
The product insert, tray label, and vial label for product codes 918610 and 918620 incorrectly state that the stoppers do not contain natural rubber latex. The recalled batches actually contain stoppers with natural rubber latex.
Context
GovInfoNow's records show Fresenius Kabi USA, LLC has had 65 other recalls since 2012-09-27. Recent brand recalls include a Tyenne Injection recall on 2026-08-10 for glass particles, Morphine Syringes recalled on 2026-08-04 for wrong labeling, and Glycopyrrolate Injection recalled on 2026-07-16 for hair in the product. Other recent recalls of similar products include a B. Braun Medical Sodium Chloride Injection recall on 2026-08-19 for particulate matter, Fresenius Kabi acyclovir injection recall on 2026-02-05 for lack of sterility assurance, and Fresenius Kabi Thiamine HCl Injection recall on 2026-02-05 for lack of sterility assurance.
How to tell if you have this one
Check for product codes 918610 or 918620 with lots from 6013062 to 6017424. These vials are packaged in 25-unit trays and labeled as Rx Only.
Brand
Fresenius Kabi
Category
Drug
FDA recall event · 2 products
All 2 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.
Look for product codes 918610 or 918620 and lots from 6013062 to 6017424 on the vial or tray.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed Nationwide in the USA and Puerto RIco” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.5 years after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class I
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-0299-2019 (November 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0299-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.