POTASSIUM CHLORIDE Inj. recall
FDA recall D-0180-2026 · initiated Oct 29, 2025
Otsuka ICU Medical LLC recalled POTASSIUM CHLORIDE Inj. in Oct 2025 — an FDA Class I recall (D-0180-2026) because 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.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
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
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: 21,696 50mL flexible containers
Details
- 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
- Recalling company
- Otsuka ICU Medical LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Oct 29, 2025
- FDA report date
- Nov 26, 2025
Frequently asked
- Was POTASSIUM CHLORIDE Inj. recalled?
- Otsuka ICU Medical LLC recalled POTASSIUM CHLORIDE Inj. in Oct 2025 — an FDA Class I recall (D-0180-2026) because 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. 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-0180-2026 was: 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
- 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: US Nationwide.. The recall covers these lots — Lot # 1030613, Exp Date: 09/30/2026. 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-0180-2026.