Class II · Moderate risk
Karina Daily Moisturizer SPF 25
CGMP Deviations
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Gabriel Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Sea Enzyme Ultra Umbrella Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Controlling Cream
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Controlling Balm with Tea Tree Oil
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50
CGMP Deviations
Class II · Moderate risk
Doctor. D. Schwab Mineral Sunscreen SPF 50
CGMP Deviations
Class III · Low risk
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class III · Low risk
Everolimus tablets 2.5 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 10 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 7.5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class II · Moderate risk
HADLIMA (adalimumab-bwwd)
Lack of Assurance of Sterility.
Class II · Moderate risk
Niacin Extended-release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II · Moderate risk
Taoscare Motion Sickness Patches 36-count box
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Class II · Moderate risk
Sucralfate Tablets
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class III · Low risk
FentaNYL Citrate PF
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ketamine Hydrochloride
Labeling: Incorrect or Missing Lot and/or Exp Date