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

5 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2011 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Actra-SX 500 Capsules

Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction

Terminated Chemical / undeclared Body Basics Inc D-265-2013
Class I · High risk

Argatroban Injection 50 mg per 50ml

A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.

Terminated Particulate / foreign matter Eagle Pharmaceuticals Inc. NDC 42367-203-07 D-1429-2012
Class I · High risk

metFORMIN ER Tablets

Labeling: Label Mix up; product labeled did not indicated Extended Release

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 53746-178-01 D-1448-2014
Class I · High risk

Oxycodone HCl Oral Concentrate

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 00527-1426-36 D-1447-2014
Class I · High risk

Taztia XT (Diltiazem HCl)

Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 62037-0696-90 D-1446-2014

Recalls by year