POTASSIUM CHLORIDE Inj — Class I drug recall D-0267-2025
Ongoing recall by ICU Medical, Inc., reported 2025-03-19, distributed nationwide. Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible cont
| Recall number | D-0267-2025 |
|---|---|
| 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) |
| Quantity | 67,488 flexible |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00309907075266, 30309907075267 |
| 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., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267
Reason for recall
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
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-0267-2025. 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.