Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

18,003 recalls, newest first

Class II · Moderate risk

Hcg - 10

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-0216-49 D-0274-2015
Class II · Moderate risk

Tri Mix PF SYR 0.5 mL Inj.

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-5036-49 D-0273-2015
Class II · Moderate risk

Hcg-20

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-2195-47 D-0272-2015
Class II · Moderate risk

Cyclosporine 0.045 % Sol PF

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-5120-67 D-0271-2015
Class II · Moderate risk

2Ml HCG 10

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-7945-17 D-0270-2015
Class II · Moderate risk

Hcg 10

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-5012-34 D-0269-2015
Class II · Moderate risk

HCG 200 IU/mL Injection

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-7745-68 D-0268-2015
Class II · Moderate risk

HCG Low Dose 10 IU / 0.1 mL

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-2596-17 D-0267-2015
Class II · Moderate risk

Tri-mix Antidote 10 each Syringes

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-0205-17 D-0266-2015
Class II · Moderate risk

HCG Low Dose 30 IU/0.1 mL

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-0231-54 D-0265-2015
Class II · Moderate risk

Testosterone Cyp 200 mg/mL Sesame Inj.

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-7906-71 D-0264-2015
Class II · Moderate risk

Phenylephrine HCl

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-5230-12 D-0263-2015
Class II · Moderate risk

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-1124-57 D-0262-2015
Class II · Moderate risk

Tri-Mix

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-5123-09 D-0261-2015
Class II · Moderate risk

Methyl B12 25 mg/mL Inj.

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-2014-37 D-0260-2015
Class II · Moderate risk

Testosterone CYP-250/PROP-20 mg

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Perry Drug Inc. NDC 88888-0326-44 D-0259-2015
Class I · High risk

Forever Beautiful INFINITY

Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein

Terminated Chemical / undeclared REFA Enterprises, LLC D-0993-2015
Class III · Low risk

Scrub Care Chlorhexidine Gluconate Solution

Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.

Terminated Unapproved drug CareFusion 213, LLC NDC 57613-007-25 D-0298-2015
Class II · Moderate risk

Mercaptopurine Tablets

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Terminated Dissolution failure Prometheus Laboratories Inc. NDC 49884-922-02 D-0249-2015
Class III · Low risk

Carbamazepine Tablets USP

Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.

Terminated Unapproved drug Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4005-3 D-0049-2015
Class III · Low risk

Z-Cote Hp 1 Transparent Zinc Oxide

cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.

Terminated cGMP deviation Nanophase Technologies Corporation D-0238-2015

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