Independent register of U.S. FDA drug recalls · updated Oct 12, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 recalls, newest first.

Class II · Moderate risk

Carvedilol Tablets

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

Terminated Particulate / foreign matter Zydus Pharmaceuticals (USA) Inc NDC 68382-095-05 D-0753-2021
Class II · Moderate risk

Mic 25/50/50mg/Ml Mdv

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

Terminated Sterility / contamination First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0062-2022
Class II · Moderate risk

Methylcobalamin 10

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

Terminated Sterility / contamination First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0058-2022
Class II · Moderate risk

Folic Acid 10mg/Ml Mdv Inj

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

Terminated Sterility / contamination First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0057-2022
Class II · Moderate risk

Calcium Gluconate 10% Inj

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

Terminated Sterility / contamination First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0056-2022
Class II · Moderate risk

Acetylcysteine 2% Opth Soln

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

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

Acetylcysteine 10% Opth Soln

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

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

Vit B Complex Inj Soln

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

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

Vit B Complex Inj Soln

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

Terminated Sterility / contamination First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0051-2022

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