POTASSIUM CHLORIDE Inj — Class I drug recall D-0180-2026
Ongoing recall by Otsuka ICU Medical LLC, reported 2025-11-26, distributed nationwide. Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIU
| Recall number | D-0180-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Otsuka ICU Medical LLC, Austin, TX, United States |
| Recall initiated | 2025-10-29 |
| Classified | 2025-11-24 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 21,696 |
| Reason classes | labeling, potency |
| NDC | 00990-7074, 00990-7074-26, 00990-7075, 00990-7075-14, 00990-7075-26, 00990-7077, 00990-7077-14, 00990-7077-26 |
| Lot numbers | 1030613 |
| Expiration dates | 2026-09-30 |
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
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
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-0180-2026. 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.