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 2020 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Smart Care HAND SANITIZER

Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches

Terminated Labeling / mix-up Ashtel Studios, INC. NDC 70108-042-01 D-0098-2021
Class I · High risk

Tranexamic Acid Injection

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

Terminated Labeling / mix-up Mylan Institutional LLC NDC 67457-197-00 D-1576-2020
Class I · High risk

Amiodarone Hydrochloride Injection

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

Terminated Labeling / mix-up Mylan Institutional LLC NDC 67457-153-99 D-1575-2020

Recalls by year