--- title: "Otsuka ICU Medical LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Otsuka ICU Medical LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/otsuka-icu-medical-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Otsuka ICU Medical LLC recall records **3** reported ongoing 5 records in this archive. Latest source date Sep 21, 2026. 2 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Sep 21, 2026 FDA company announcement ### [ICU Medical LLC: 0.9% Sodium Chloride Injection, USP, 100 mL](https://isitonrecall.com/recall/fdapress-2074d1211e5be838-icu-medical-llc-0-9-sodium-chloride-injection-usp-100-ml/) Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection Not supplied Published notice; closure not supplied Distribution: Affected Product: The affected product lot was manufactured on 13 November 2025 and distributed in the United States between 30 December 2025 and 22 June 2026. An image of the o... [Official source for ICU Medical LLC: 0.9% Sodium Chloride Injection, USP, 100 mL](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-due) Nov 3, 2025 FDA company announcement ### [ICU Medical: 20 mEq Potassium Chloride Injection](https://isitonrecall.com/recall/fdapress-247b9240aed289b9-icu-medical-20-meq-potassium-chloride-injection/) Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection Not supplied Published notice; closure not supplied Distribution: The affected product lot was manufactured on 15 April 2025 and distributed in the United States between 23 May 2025 through 26 August 2025. The affected product lot (Located on ... [Official source for ICU Medical: 20 mEq Potassium Chloride Injection](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due) Oct 29, 2025 FDA drug enforcement ### [POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14](https://isitonrecall.com/recall/fda-drug-d-0180-2026-potassium-chloride-inj-20-meq-total-in-50-ml-flexible-container-highly-concentrated-400-meq-l-rx-onl/) Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq Class I Reported ongoing Distribution: US Nationwide. [Official source for POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0180-2026%22) Oct 29, 2025 FDA drug enforcement ### [POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26](https://isitonrecall.com/recall/fda-drug-d-0181-2026-potassium-chloride-inj-10-meq-total-in-100-ml-flexible-container-highly-concentrated-100-meq-l-rx-on/) Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq Class I Reported ongoing Distribution: US Nationwide. [Official source for POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0181-2026%22) Oct 27, 2025 FDA drug enforcement ### [0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37](https://isitonrecall.com/recall/fda-drug-d-0143-2026-0-9-sodium-chloride-injection-usp-100-ml-rx-only-icu-medical-inc-lake-forest-illinois-60045-usa-ndc/) Lack of Assurance of Sterility: Potential for flexible container leaks. Class II Reported ongoing Distribution: Distributed Nationwide in the USA. [Official source for 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 6...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0143-2026%22) ## Reasons in these listed records - Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection - Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection - Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq - Lack of Assurance of Sterility: Potential for flexible container leaks. These examples come from this result page and are not a ranking of every recall reason. ## Checking Otsuka ICU Medical LLC ### Is there a recall on otsuka icu medical llc right now? This archive contains 5 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Otsuka ICU Medical LLC](https://isitonrecall.com/check/?q=Otsuka%20ICU%20Medical%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)