Class II · Moderate risk
All methyltestosterone Products
Lack of Processing Controls
Manufacturing (cGMP) deviations
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards.
1,754 FDA drug recalls with this cause, newest first.
This category covers departures from current Good Manufacturing Practice during production. It is FDA's broadest label, used when a facility's own process control failed somewhere along the line even if no single ingredient was proven unsafe on its own. Where the report names a specific consequence - a temperature excursion, a contaminant, a potency problem - we file the recall under that more specific cause instead; what remains here is the genuinely general case.
Class II · Moderate risk
All ketamine and amitriptyline Products
Lack of Processing Controls
Class II · Moderate risk
All estradiol Products
Lack of Processing Controls
Class II · Moderate risk
All dyclonine Products
Lack of Processing Controls
Class II · Moderate risk
All doxycycline Products
Lack of Processing Controls
Class II · Moderate risk
All sucralfate Products
Lack of Processing Controls
Class II · Moderate risk
All fluconazole Products
Lack of Processing Controls
Class II · Moderate risk
All acyclovir and lidocaine Products
Lack of Processing Controls
Class II · Moderate risk
All hydroxyurea Products
Lack of Processing Controls
Class II · Moderate risk
All diltiazem Products
Lack of Processing Controls
Class II · Moderate risk
All cocaine Products
Lack of Processing Controls
Class II · Moderate risk
All capsicum Products
Lack of Processing Controls
Class II · Moderate risk
All quinacrine Products
Lack of Processing Controls
Class II · Moderate risk
All Arimidex
Lack of Processing Controls
Class II · Moderate risk
All phenylephrine Products
Lack of Processing Controls
Class II · Moderate risk
All Coal Tar Products
Lack of Processing Controls
Class II · Moderate risk
All retinoic acid Products
Lack of Processing Controls
Class II · Moderate risk
All Midrin
Lack of Processing Controls
Class II · Moderate risk
All sulfapyridine Products
Lack of Processing Controls
Class II · Moderate risk
All squaric acid Products
Lack of Processing Controls
Class II · Moderate risk
All ketoprofen Products
Lack of Processing Controls
Class II · Moderate risk
All mirtazapine Products
Lack of Processing Controls
Class II · Moderate risk
All T3 Products
Lack of Processing Controls
Class II · Moderate risk
All thyroid Products
Lack of Processing Controls
Class II · Moderate risk
All lidocaine
Lack of Processing Controls
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