US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Papa/Phento

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0178-2016
Class II · Moderate risk Terminated

PGE 30mcg/ml Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0177-2016
Class II · Moderate risk Terminated

Papa/Pge1/Phento

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0176-2016
Class II · Moderate risk Terminated

Papa/Pge1/Phento

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0175-2016
Class II · Moderate risk Terminated

Papa/Pge1/Phento

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0174-2016
Class II · Moderate risk Terminated

Papa/Pge1/Phento

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0173-2016
Class II · Moderate risk Terminated

Papa/Pge1/Phento

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0172-2016
Class II · Moderate risk Terminated

PGE 20mcg/ml Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0171-2016
Class II · Moderate risk Terminated

Papa/Phento

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0170-2016
Class II · Moderate risk Terminated

Papa+pge1+phento

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0169-2016
Class II · Moderate risk Terminated

Testosterone prop. 200 mg/ml Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0168-2016
Class II · Moderate risk Terminated

Testosterone Cypionate 250 mg/mL Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0167-2016
Class II · Moderate risk Terminated

Nandrolone 200 mg/ml Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0166-2016
Class II · Moderate risk Terminated

Stanozolol 200 mg/ml Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pacific Healthcare, Inc dba B&B Pharmacy D-0165-2016
Class II · Moderate risk Terminated

Tri-Mix 20mcg+0.5mg+15mg/Ml

Reason Lack of Assurance of Sterility: all sterile compounded products within expiry

Chen Shwezin, Inc. dba Park Compounding Pharmacy D-0160-2016
Class II · Moderate risk Terminated

Caffeine + Sodium Benzoate 500mg/Ml

Reason Lack of Assurance of Sterility: all sterile compounded products within expiry

Chen Shwezin, Inc. dba Park Compounding Pharmacy D-0159-2016
Class II · Moderate risk Terminated

Tri-Mix 10mcg+0.5mg+15mg/Ml

Reason Lack of Assurance of Sterility: all sterile compounded products within expiry

Chen Shwezin, Inc. dba Park Compounding Pharmacy D-0158-2016
Class II · Moderate risk Terminated

Methylcobalamin 1000mcg/Ml

Reason Lack of Assurance of Sterility: all sterile compounded products within expiry

Chen Shwezin, Inc. dba Park Compounding Pharmacy D-0157-2016
Class II · Moderate risk Terminated

Prostaglandin Pge-1 40mcg/Ml

Reason Lack of Assurance of Sterility: all sterile compounded products within expiry

Chen Shwezin, Inc. dba Park Compounding Pharmacy D-0156-2016
Class II · Moderate risk Terminated

Metformin Hydrochloride Extended-Release Tablets

Reason Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.

Actavis Laboratories, FL, Inc. NDC 0591-2720-60 D-0014-2016
Class II · Moderate risk Terminated

Xanax

Reason Subpotent Drug

Pfizer Inc. NDC 0009-0029-01 D-0161-2016
Class II · Moderate risk Terminated

Sermorelin 6mg/6mL Lyophilized Powder

Reason Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.

Diabetes Corporation of America dba DCA Pharmacy D-0006-2016
Class II · Moderate risk Terminated

P-P-P

Reason Lack of assurance of sterility

Bedford Pharmacy D-0050-2016