POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only,...

FDA Drug Recall #D-0267-2025 — Class I — February 13, 2025

Recall Summary

Recall Number D-0267-2025
Classification Class I — Serious risk
Date Initiated February 13, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ICU Medical, Inc.
Location Lake Forest, IL
Product Type Drugs
Quantity 67,488 flexible containers

Product Description

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

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Lot 1023172, Exp Date: 31 January 2026

Other Recalls from ICU Medical, Inc.

Recall # Classification Product Date
D-0268-2025 Class I POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL... Feb 13, 2025

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.