Class II · Moderate risk
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
FDA Drug Recalls
560 recalls, newest first
Class II · Moderate risk
Semaglutide-Glycine-Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Lack of Assurance of Sterility
Class II · Moderate risk
SLMD Benzoyl Peroxide Acne Lotion
Chemical contamination: Presence of benzene
Class II · Moderate risk
SLMD BP Acne Spot Treatment
Chemical contamination: Presence of benzene
Class II · Moderate risk
HydroPeptide CLEAR ALLIANCE SERUM
Chemical contamination: Presence of benzene
Class II · Moderate risk
FHF Farmhouse Fresh
Chemical contamination: Presence of benzene
Class II · Moderate risk
Artificial Tears Sterile Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Eye Drops Soothing Tears
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile EYE DROPS REDNESS LUBRICANT
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Eye Drops ORIGINAL FORMULA
Lack of Assurance of Sterility
Class II · Moderate risk
Ultra Lubricating Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Dry Eye Relief Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
EYE DROPS Advanced Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile EYE DROPS AC
Lack of Assurance of Sterility
Class II · Moderate risk
Product label: Temozolomide Capsules
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Class I · High risk
Webcol Alcohol Prep pad
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Class II · Moderate risk
Levothyroxine Sodium Tablets USP 150 mcg
Subpotent Drug
Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Amnesteem (Isotretinoin)
Failed Dissolution Specifications
Class III · Low risk
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit
Failed Tablet/Capsule Specifications