US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

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

Benzalkonium Chloride 0.013% Solution

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0055-2022
Class II · Moderate risk Terminated

Acetylcysteine 2% Opth Soln

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0054-2022
Class II · Moderate risk Terminated

Acetylcysteine 10% Opth Soln

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0053-2022
Class II · Moderate risk Terminated

Vit B Complex Inj Soln

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0052-2022
Class II · Moderate risk Terminated

Vit B Complex Inj Soln

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0051-2022
Class II · Moderate risk Terminated

Testosterone Ultra 250mg/Ml Mdv in Sesame Oil

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0050-2022
Class II · Moderate risk Terminated

Test Cyp/Prop/Deca-Nan 125mg/Ml

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0049-2022
Class II · Moderate risk Terminated

Test Cyp/Prop/Deca-Nan 125mg/Ml

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0048-2022
Class II · Moderate risk Terminated

Test Cyp/Prop 160/40mg/Ml Mdv in Ethyl Oleate

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0047-2022
Class II · Moderate risk Terminated

Test Cyp 50mg/Ml in Ethyl Oleate Oil

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0046-2022
Class II · Moderate risk Terminated

Test Cyp 25mg/Ml in Ethyl Oleate Mdv

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0045-2022
Class II · Moderate risk Terminated

Test Cyp 200mg/Ml Mdv Ethyl Oleate

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0044-2022
Class II · Moderate risk Terminated

Test Cyp 200mg/Ml in Sesame Oil Mdv

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0043-2022
Class II · Moderate risk Terminated

Test Cyp 100mg/Ml in Ethyl Oleate Oil

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0042-2022
Class II · Moderate risk Terminated

Pyridoxine HCL

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0041-2022
Class II · Moderate risk Terminated

Levocarnitine 100mg/Ml Mdv Soln

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0040-2022
Class II · Moderate risk Terminated

Hydroxyprog Caproate 250mg/Ml Oil Inj

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0039-2022
Class II · Moderate risk Terminated

Glutathione 200mg/Ml Mdv

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0038-2022
Class II · Moderate risk Terminated

Estradiol Valerate 5mg/Ml Mdv Inj

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0037-2022
Class II · Moderate risk Terminated

Dexpanthenol 250mg/Ml Inj Soln

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0036-2022
Class II · Moderate risk Terminated

Cyclosporine 2% Mct Oil Susp

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0035-2022
Class II · Moderate risk Terminated

Cyclosporin 0.2% Oil Opth Susp

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0034-2022
Class II · Moderate risk Terminated

Ascorbic/Glutathione 1.25/1.25% Opth Soln

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0033-2022
Class II · Moderate risk Terminated

Ascorbic Acid

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0032-2022
Class II · Moderate risk Terminated

Ascorbic Acid

Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0031-2022