POTASSIUM CHLORIDE Inj. recall
FDA recall D-0267-2025 · initiated Feb 13, 2025
ICU Medical, Inc. recalled POTASSIUM CHLORIDE Inj. in Feb 2025 — an FDA Class I recall (D-0267-2025) because 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.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 67,488 flexible containers
Details
- 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
- Recalling company
- Icu Medical Inc
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 13, 2025
- FDA report date
- Mar 19, 2025
Frequently asked
- Was POTASSIUM CHLORIDE Inj. recalled?
- ICU Medical, Inc. recalled POTASSIUM CHLORIDE Inj. in Feb 2025 — an FDA Class I recall (D-0267-2025) because 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. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was POTASSIUM CHLORIDE Inj. recalled?
- Per the FDA enforcement record, the reason for recall D-0267-2025 was: 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.
- Is a recalled POTASSIUM CHLORIDE Inj. dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of POTASSIUM CHLORIDE Inj. are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot 1023172, Exp Date: 31 January 2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0267-2025.