Why it was recalled
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
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 1030613, Exp Date: 09/30/2026
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0180-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Oct 29, 2025
- FDA report date
- Nov 26, 2025
- Quantity
- 21,696 50mL flexible containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Otsuka ICU Medical LLC
Original FDA data
Every field from FDA enforcement report D-0180-2026, exactly as published.
Show all FDA fields
- City
- Austin
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 97888
- Address
- 3900 Howard Ln
- Code information
- Lot # 1030613, Exp Date: 09/30/2026
- Postal code
- 78728-6515
- Report date
- Nov 26, 2025
- Product type
- Drugs
- Recall number
- D-0180-2026
- Classification
- Class I
- Recalling firm
- Otsuka ICU Medical LLC
- Product quantity
- 21,696 50mL flexible containers
- Reason for recall
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Oct 29, 2025
- Initial firm notification
- Letter
- Center classification date
- Nov 24, 2025