Urgent site urgencyFDA Class I

POTASSIUM CHLORIDE Inj

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

Agency
FDA Drug
Recall date
Oct 29, 2025
Status
Ongoing
Company
Otsuka ICU Medical LLC
Incorrect Overwrap label showing 10 mEq Potassium chloride injection
Image supplied with the official CPSC notice.

1. What product was recalled?

POTASSIUM CHLORIDE Inj

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

Code or lot text: Lot # 1030613, Exp Date: 09/30/2026

LOT
Exp Date: 09/30/2026
LOT
Lot # 1030613
NDC
0990-7074
NDC
0990-7074-26
NDC
0990-7075
NDC
0990-7075-14
NDC
0990-7075-26
NDC
0990-7077
NDC
0990-7077-14
NDC
0990-7077-26
RECALL-NUMBER
D-0181-2026

POTASSIUM CHLORIDE Inj

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

Quantity: 21,696 50mL flexible containers

Code or lot text: Lot # 1030613, Exp Date: 09/30/2026

LOT
Exp Date: 09/30/2026
LOT
Lot # 1030613
NDC
0990-7074
NDC
0990-7074-26
NDC
0990-7075
NDC
0990-7075-14
NDC
0990-7075-26
NDC
0990-7077
NDC
0990-7077-14
NDC
0990-7077-26
RECALL-NUMBER
D-0180-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Drug source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.