Class II · Moderate risk Ongoing
SEMAGLUTIDE 10mg/4mL
Reason Lack of Assurance of Sterility
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
SEMAGLUTIDE 5mg/2mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide 2 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Lidocaine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Ibuprofen 800mg
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II · Moderate risk Ongoing
Ibuprofen Tablets
Reason Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class II · Moderate risk Ongoing
Testosterone Gel
Reason Superpotent Drug
Class II · Moderate risk Ongoing
IBU Ibuprofen Tablets
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk Ongoing
IBU Ibuprofen Tablets
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk Ongoing
IBU Ibuprofen Tablets
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules
Reason Failed Dissolution Specifications: below specification results
Class II · Moderate risk Ongoing
Progesterone Injection
Reason Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class II · Moderate risk Ongoing
Ciprofloxacin ophthalmic solution USP
Reason Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Glenmark
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective container; yellow colored spike from cap lodged in the nozzle
Class II · Moderate risk Ongoing
Lidocaine HCL Injection
Reason Subpotent Drug: reduced efficacy for epinephrine
Class II · Moderate risk Ongoing
Decitabine for Injection 50mg per vial
Reason CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason Failed Dissolution Specifications: results below specifications
Class II · Moderate risk Ongoing
Fludrocortisone Acetate Tablets
Reason Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Class II · Moderate risk Ongoing
Infla-650 Herbal Dietary Supplement
Reason Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Class II · Moderate risk Ongoing
buPROPion Hydrochloride Extended-release Tablets USP
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations