Class II · Moderate risk
Human Chorionic Gonadotropin 5
CGMP deviations: Lack of potency testing.
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Class II · Moderate risk
Human Chorionic Gonadotropin 6
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 11
CGMP deviations: Lack of potency testing.
Class III · Low risk
Fentanyl
Subpotency: Out-of-specification stability test result for low potency was obtained.
Class III · Low risk
Scandonest 3% Plain
Labeling: Label mix-up
Class II · Moderate risk
Irinotecan Hydrochloride Injection
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Class II · Moderate risk
CVS Health Hydrating Healing Ointment
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Class II · Moderate risk
Aripiprazole Tablets
Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk
Immune Boost with natural strawberry flavor
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Class II · Moderate risk
Athlete's Foot Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
TopCare Health
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Best Choice
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
RiteAid Pharmacy RIngworm Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kroger Jock Itch Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kroger Athlete's Foot Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kaiser Permanente Clotrimazole Cream USP
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
H-E-B - Athlete's Foot Cream Clotrimazole Cream USP
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Equate Athlete's Foot
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
CVS Health Athlete's Foot Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kollidon CL-M Crospovidone Ph.Eur.Type B
Cross contamination: the excipient was found to be contaminated with theophylline.
Class I · High risk
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Cross Contamination with other products: trace amounts of lidocaine
Class I · High risk
Regenecare Ha
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Class II · Moderate risk
Aripiprazole Tablets
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Class III · Low risk
DOXOrubicin Hydrochloride Injection
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Class III · Low risk
Levocetirizine Dihydrochloride Tablets
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.