POTASSIUM CHLORIDE Inj — Class I drug recall D-0268-2025
Ongoing recall by ICU Medical, Inc., reported 2025-03-19, distributed nationwide. Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flex
| Recall number | D-0268-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., Lake Forest, IL, United States |
| Recall initiated | 2025-02-13 |
| Classified | 2025-03-10 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00309907074269 |
| NDC | 00990-7074, 00990-7074-26, 00990-7075, 00990-7075-14, 00990-7075-26, 00990-7077, 00990-7077-14, 00990-7077-26 |
| Lot numbers | 1023172 |
| Expiration dates | 2026-01-31 |
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 for recall
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0268-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.