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

4 recalls · Class III, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2017 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class III · Low risk

Bull Capsules

Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil

Terminated Chemical / undeclared BYL Solutions Inc. D-0414-2018
Class III · Low risk

Norethindrone Acetate and Ethinyl Estradiol Tablets

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

Terminated Chemical / undeclared Mylan Pharmaceuticals Inc. NDC 0378-7280-85 D-0861-2017
Class III · Low risk

Tarina Fe 1/20

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

Terminated Chemical / undeclared Mylan Pharmaceuticals Inc. NDC 50102-128-01 D-0860-2017

Recalls by year