Otsuka ICU Medical LLC recalls POTASSIUM CHLORIDE Inj.
- Recalling company
- Otsuka ICU Medical LLC
- Product
- 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
- Reason
- 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
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Oct 29, 2025
- Reported
- Nov 26, 2025
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- 21,696 50mL flexible containers
- Lot / codes
- Lot # 1030613, Exp Date: 09/30/2026
- Company location
- Austin, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0180-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0180-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.