FDA Drug recall D-0180-2026
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest,…
- FDA Drug
- Class I
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class I recall of POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest,… by Otsuka Icu Medical, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0180-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-10-29 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Otsuka Icu Medical |
| Distribution | US |
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
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
Identifiers
| ndc | 0990-7074-26 |
|---|---|
| ndc | 0990-7075-14 |
| ndc | 0990-7075-26 |
| ndc | 0990-7077-14 |
| ndc | 0990-7077-26 |
| code_info | Lot # 1030613, Exp Date: 09/30/2026 |
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-0180-2026%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.