Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
POTASSIUM CHLORIDE Inj.
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267
Affected NDC
0990-7075-26
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Potassium Chloride NDC 00990-7075 |
200 meq/1000mL | Injection, Solution Intravenous |
ICU Medical Inc. | Rx |
- Recalling firm
- ICU Medical, Inc.
- NDC code
- 0990-7075-26
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0267-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other recalls by ICU Medical, Inc.
All 2025 recalls
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Class I · High risk
AMINOSYN II 15% An Amino Acid Injection
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Class II · Moderate risk
0.9% SODIUM CHLORIDE Irrigation
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Other labeling / mix-up recalls from 2025
All labeling / mix-up recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class III · Low risk
parodontax
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg / 5 mL
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class I · High risk
POTASSIUM CHLORIDE Inj.
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
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