Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

31 recalls, newest first

Class II · Moderate risk

Dexonto 0.4%

Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.

Ongoing Labeling / mix-up Nubratori, Inc NDC 71300-6564-1 D-0392-2025
Class I · High risk

Levetiracetam 0.75% in Sodium Chloride Injection 1

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

Ongoing Labeling / mix-up Dr. Reddy's Laboratories, Inc. NDC 43598-636-52 D-0365-2025
Class I · High risk

POTASSIUM CHLORIDE Inj.

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

Ongoing Labeling / mix-up ICU Medical, Inc. NDC 0990-7074-26 D-0268-2025
Class I · High risk

POTASSIUM CHLORIDE Inj.

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.

Ongoing Labeling / mix-up ICU Medical, Inc. NDC 0990-7075-26 D-0267-2025
Class III · Low risk

Badger 50

Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.

Terminated Labeling / mix-up The W.S. Badger Company, Inc. D-0209-2025

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