US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

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.

Abbott's Compounding Pharmacy, Inc. D-0696-2016
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.

Abbott's Compounding Pharmacy, Inc. D-0695-2016
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.

Abbott's Compounding Pharmacy, Inc. D-0694-2016
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.

Abbott's Compounding Pharmacy, Inc. D-0693-2016
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.

Abbott's Compounding Pharmacy, Inc. D-0692-2016
Class II · Moderate risk Terminated

papaverine phentolamine

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.

Abbott's Compounding Pharmacy, Inc. D-0691-2016
Class II · Moderate risk Terminated

papaverine phentolamine 30 mg/1mg/mL

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.

Abbott's Compounding Pharmacy, Inc. D-0690-2016
Class II · Moderate risk Terminated

papaverine prostaglandin 30 mg/20 mcg/mL

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.

Abbott's Compounding Pharmacy, Inc. D-0689-2016
Class II · Moderate risk Terminated

papaverine prostaglandin 30 mg/30 mcg/mL

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.

Abbott's Compounding Pharmacy, Inc. D-0688-2016
Class II · Moderate risk Terminated

methylcobalamine 4 mg/mL

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.

Abbott's Compounding Pharmacy, Inc. D-0687-2016
Class II · Moderate risk Terminated

methylcobalamine 1 mg/mL

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.

Abbott's Compounding Pharmacy, Inc. D-0686-2016
Class II · Moderate risk Terminated

methylcobalamine 10 mg/mL

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.

Abbott's Compounding Pharmacy, Inc. D-0685-2016
Class II · Moderate risk Terminated

Insulin

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.

Abbott's Compounding Pharmacy, Inc. D-0684-2016
Class II · Moderate risk Terminated

hydroxyprogesterone w/ pres

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.

Abbott's Compounding Pharmacy, Inc. D-0683-2016
Class II · Moderate risk Terminated

hydroxyprogesterone in sesame 250 mg/mL

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.

Abbott's Compounding Pharmacy, Inc. D-0682-2016
Class II · Moderate risk Terminated

Hydroxycobalamine 30 mg/mL

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.

Abbott's Compounding Pharmacy, Inc. D-0681-2016
Class II · Moderate risk Terminated

Folic Acid

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.

Abbott's Compounding Pharmacy, Inc. D-0680-2016
Class II · Moderate risk Terminated

Folic Acid

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.

Abbott's Compounding Pharmacy, Inc. D-0679-2016
Class II · Moderate risk Terminated

Estradiol cypionate/Test cyprionate

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.

Abbott's Compounding Pharmacy, Inc. D-0678-2016
Class II · Moderate risk Terminated

calcium elemental

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.

Abbott's Compounding Pharmacy, Inc. D-0677-2016
Class II · Moderate risk Terminated

Bupivacaine

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.

Abbott's Compounding Pharmacy, Inc. D-0676-2016
Class III · Low risk Terminated

risperiDONE ORALLY DISINTEGRATING TABLETS

Reason Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

Zydus Pharmaceuticals USA Inc D-0725-2016
Class II · Moderate risk Terminated

Lyrica

Reason FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.

Pfizer Inc. NDC 0071-1014-68 D-0649-2016
Class II · Moderate risk Terminated

Lyrica

Reason FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.

Pfizer Inc. NDC 0071-1013-68 D-0648-2016
Class I · High risk Terminated

Zhen Gong Fu

Reason Marketed Without An Approved NDA/ANDA

R Thomas Marketing, LLC D-0907-2016