FDA Drug recall D-0268-2025
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, US…
- FDA Drug
- Class I
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class I recall of POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, US… by Icu Medical, citing labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0268-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-13 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
Reason
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Identifiers
| ndc | 0990-7074-26 |
|---|---|
| ndc | 0990-7075-14 |
| ndc | 0990-7075-26 |
| ndc | 0990-7077-14 |
| ndc | 0990-7077-26 |
| ndc | 0030990707 |
| code_info | Lot 1023172, Exp Date: 31 January 2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0268-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.