Class II · Moderate risk
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL
Lack of Assurance of Sterility
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class II · Moderate risk
SEMAGLUTIDE 10mg/4mL
Lack of Assurance of Sterility
Class II · Moderate risk
SEMAGLUTIDE 5mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide 2 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
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
Ibuprofen 800mg
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class II · Moderate risk
Testosterone Gel
Superpotent Drug
Class II · Moderate risk
IBU Ibuprofen Tablets
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
IBU Ibuprofen Tablets
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
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class I · High risk
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk
Indomethacin Extended-Release Capsules
Failed Dissolution Specifications: below specification results
Class II · Moderate risk
Progesterone Injection
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter
Class II · Moderate risk
Ciprofloxacin ophthalmic solution USP
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
Glenmark
CGMP Deviations
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective container; yellow colored spike from cap lodged in the nozzle
Class I · High risk
Umary Acido Hialuronico
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk
Umary Acido Hialuronico
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk
Gold Hard Steel Plus Liquid
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk
Healthy Living Acetaminophen
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.