Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable
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
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Tobramycin Irrigation 80 mg/1000 mL Solution
Lack of Processing Controls
Class II · Moderate risk
Gentamicin
Lack of Processing Controls
Class II · Moderate risk
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection
Lack of Processing Controls
Class II · Moderate risk
Alprostadil 100 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Acetylcysteine 2% Otic Drop
Lack of Processing Controls
Class II · Moderate risk
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class II · Moderate risk
Fungo Off Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Asma Stopper Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Anemia Off
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Appetrol Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Mental Tonic Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Thyro-Lo
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Smoke End Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Detensin
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Yeast Douche Powder
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Worm Off
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Vertigo Off Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Thyro-H
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Stone Purger Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Stomach Flu Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Sperm Booster
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Psoriasis Balm
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk
Prostatin Capsules
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.