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

Edetate Calcium Disodium Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-362-2013
Class II · Moderate risk

Edetate Disodium Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-361-2013
Class II · Moderate risk

Dimethyl Sulfoxide

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-360-2013
Class II · Moderate risk

Dimercapto-propane-sulfonic acid

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-359-2013
Class II · Moderate risk

Dexpanthenol Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-358-2013
Class II · Moderate risk

Dexamethasone Sodium Phosphate Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-357-2013
Class II · Moderate risk

Cyclosporine Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-356-2013
Class II · Moderate risk

Cyanocobalamin Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-355-2013
Class II · Moderate risk

Vitamin D3 Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-354-2013
Class II · Moderate risk

Buprenorphine Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-353-2013
Class II · Moderate risk

Bupivacaine Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-352-2013
Class II · Moderate risk

Bupivacaine and Dexamethasone Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-351-2013
Class II · Moderate risk

Biotin Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-350-2013
Class II · Moderate risk

Betamethasone Sodium Phosphate Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-348-2013
Class II · Moderate risk

BET-ACE-LIDO-6-2 Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-347-2013
Class II · Moderate risk

Betamethasone Combination Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-346-2013
Class II · Moderate risk

B-Complex Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-345-2013
Class II · Moderate risk

Bacteriostatic Water for Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-344-2013
Class II · Moderate risk

Betamethasone Acetate and Betamethasone Sodium Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-343-2013
Class II · Moderate risk

Ascorbic Acid Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-342-2013
Class II · Moderate risk

Amikacin Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-341-2013
Class II · Moderate risk

Alpha Lipoic Acid Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-340-2013
Class II · Moderate risk

Acetylcysteine Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-339-2013
Class II · Moderate risk

(No Brand) First Aid Kit

CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.

Terminated Stability / shelf life Total Resources Intl D-891-2013

Recalls by year