Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
0.45% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Icosapent Ethyl Capsules
Reason Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Class II · Moderate risk Ongoing
Semaglutide-Glycine-Cyanocobalamin Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
SLMD Benzoyl Peroxide Acne Lotion
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Ongoing
SLMD BP Acne Spot Treatment
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Ongoing
HydroPeptide CLEAR ALLIANCE SERUM
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Ongoing
FHF Farmhouse Fresh
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Ongoing
Artificial Tears Sterile Lubricant Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sterile Eye Drops Soothing Tears
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sterile EYE DROPS REDNESS LUBRICANT
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sterile Eye Drops ORIGINAL FORMULA
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Lubricating Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dry Eye Relief Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
EYE DROPS Advanced Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sterile EYE DROPS AC
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Product label: Temozolomide Capsules
Reason Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Class II · Moderate risk Ongoing
Children's Ibuprofen Oral Suspension
Reason Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP 150 mcg
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Tirzepatide Inj
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide Inj
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Inj.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Inj
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Amnesteem
Reason Failed Dissolution Specifications