Potassium Chloride Injection Recalled: Overwrap Labeling Shows Incorrect Strength
ICU Medical recalls Potassium Chloride 20 mEq IV injection due to mislabeled overwrap showing 10 mEq instead of the correct strength. The correct dose is printed on the actual container.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies to this recall, establishing a minimum severity of Severe. The mislabeling of an intravenous medication's strength creates risk for dosing errors in clinical use.
Plain-English summary
ICU Medical is recalling Potassium Chloride Intravenous Injection, 20 mEq in 100 mL flexible containers. The affected lot is 1023172, expiring January 31, 2026, and the product was distributed nationwide in the USA. Approximately 67,488 flexible containers are involved in the recall.
The issue is a labeling error: cases labeled Potassium Chloride 20 mEq may contain flexible containers with overwrap mislabeled as 10 mEq. However, the correct dosage strength of 20 mEq is printed on the labeling attached to the product's flexible container. The mislabeling on the external overwrap creates potential for medication errors.
Healthcare providers and patients should use the dosage strength shown on the flexible container's attached label, not the overwrap label. Containers from lot 1023172 should be carefully verified before use to confirm correct strength labeling on the container itself.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- ICU Medical, Inc.
- Category
- Drug — Intravenous electrolyte
- Hazard
- Affected units
- 67,488
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1023172
- Exp Date: 31 January 2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by ICU Medical, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · POTASSIUM CHLORIDE
- CriticalPotassium chloride bags recalled because the overwrap understates the declared strength
FDA (Drugs) · 2025-11-26
- CriticalConcentrated potassium chloride recalled over an understated strength on the overwrap
FDA (Drugs) · 2025-11-26
- SeverePotassium Chloride Injection Strength Mislabeled on Packaging Overwrap
FDA (Drugs) · 2025-03-19
- HighPotassium Chloride Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2025-02-12
- SeverePotassium Chloride Extended-Release Capsules Recalled Over Failed Dissolution
FDA (Drugs) · 2024-08-07
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- CriticalConcentrated potassium chloride recalled over an understated strength on the overwrap
FDA (Drugs) · 2025-11-26
- CriticalPotassium chloride bags recalled because the overwrap understates the declared strength
FDA (Drugs) · 2025-11-26
- ModerateBaxter Recalls Potassium Chloride Injection Bags Due to Labeling Error
FDA (Drugs) · 2014-12-03
- ModerateMedi-Fare Recalls Potassium Chloride Syringes Due to Fill Volume Error
FDA (Drugs) · 2018-07-18
- SevereBaxter Recalls Potassium Chloride Bags Due to Mispackaging Error
FDA (Drugs) · 2014-10-01
- ModeratePharmedium Recalls Potassium Chloride Injection Bags Due to Labeling Error
FDA (Drugs) · 2016-06-15