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

3 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Digoxin Tablets

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Terminated Labeling / mix-up Marlex Pharmaceuticals, Inc. NDC 10135-0747-01 D-1169-2023
Class I · High risk

ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg

Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

Terminated Labeling / mix-up The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-6269-08 D-0893-2023
Class I · High risk

G-Supress DX

Product mix-up: incorrect product was found inside the G-Supress DX product carton.

Terminated Labeling / mix-up Novis PR, LLC dba Kramer Novis NDC 52083-655-01 D-0868-2023

Recalls by year