Otsuka ICU Medical LLC drug recall: POTASSIUM CHLORIDE Inj

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

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Oct 29, 2025. FDA classified it 26 days later, on Nov 24, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide. Otsuka ICU Medical LLC has 2 recalls in our records.

Recalled products (2)

• D-0180-2026 Class I Ongoing

  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

  Codes / lots: Lot # 1030613, Exp Date: 09/30/2026

  Quantity: 21,696 50mL flexible containers

• D-0181-2026 Class I Ongoing

  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

  Codes / lots: Lot # 1030613, Exp Date: 09/30/2026