Class III · Low risk
Clobetasol Propionate Topical Solution USP
Defective Container; complaints of leakage.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class II · Moderate risk
Lipoic Acid Injection
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Class II · Moderate risk
Cephalexin for Oral Suspension USP 250mg/5 mL
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Class I · High risk
5K Premium Enhancement capsule
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Class II · Moderate risk
Cephalexin for Oral Suspension USP
CGMP Deviation; manufacturing batch record could not be located
Class I · High risk
Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class I · High risk
Vecuronium Bromide for Injection 10 mg*
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class II · Moderate risk
Lidocaine gel 1%
Lack of sterility assurance.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.05%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.2%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.5%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 1%
Lack of sterility assurance.
Class II · Moderate risk
Vitamin B12 liquid 1000mcg/ml
Lack of sterility assurance.
Class II · Moderate risk
Testosteron Cypionate liquid 200mg/ml
Lack of sterility assurance.
Class II · Moderate risk
Methocarbamol liquid 100mg/ml
Lack of sterility assurance.
Class II · Moderate risk
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine/Epinepherine liquid 1%/ 1:1000
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine gel 2%
Lack of sterility assurance.
Class II · Moderate risk
Hydroxyprogesterone liquid
Lack of sterility assurance.
Class II · Moderate risk
HCG liquid
Lack of sterility assurance.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.
Class II · Moderate risk
Epinephrine liquid 1:1000
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 2%
Lack of sterility assurance.