Multi event Drug Recall Enforcement Report Class I voluntary initiated by Otsuka ICU Medical LLC, originally initiated on 10-29-2025 for the 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 The product was recalled due to 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. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0180-2026 | 10-29-2025 | 11-26-2025 | Class I | 21,696 50mL flexible containers | 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 | 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 | Ongoing |
| D-0181-2026 | 10-29-2025 | 11-26-2025 | Class I | | 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 | 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 | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0990-7074 | Potassium Chloride | Potassium Chloride | Injection, Solution | Intravenous | Icu Medical Inc. | Human Prescription Drug |
| 0990-7075 | Potassium Chloride | Potassium Chloride | Injection, Solution | Intravenous | Icu Medical Inc. | Human Prescription Drug |
| 0990-7077 | Potassium Chloride | Potassium Chloride | Injection, Solution | Intravenous | Icu Medical Inc. | Human Prescription Drug |
