Class II · Moderate risk Terminated
Levofloxacin Tablets USP
Reason Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
Licorice Coughing Liquid
Reason Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
Class III · Low risk Terminated
Virt-Nate Prenatal/Postnatal
Reason Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
Class II · Moderate risk Terminated
papaverine phent
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
testosterone cypionate
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
testosterone cypionate
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
progesterone/testosterone
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.