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

Quadmix Custom Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-285-2013
Class II · Moderate risk

BiMix Plus Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-284-2013
Class II · Moderate risk

BiMix Standard Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-283-2013
Class II · Moderate risk

Trimix Customs Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-282-2013
Class II · Moderate risk

Mono-mix (Prostaglandin)

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-281-2013
Class II · Moderate risk

Phosphatidylcholine Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-279-2013
Class II · Moderate risk

Cyclosporin

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-278-2013
Class II · Moderate risk

Progesterone in Olive Oil Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-277-2013
Class II · Moderate risk

Methylcobalamin and Folic Acid Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-276-2013
Class II · Moderate risk

Cyanocobalamin

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-275-2013
Class II · Moderate risk

Triamcinolone Hexacetonide Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-274-2013
Class II · Moderate risk

Betamethasone Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-273-2013
Class II · Moderate risk

Sodium Tetradecyl Sulfate Injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-272-2013
Class II · Moderate risk

Methylprednisolone Acetate injectable Balanced Solutions

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-271-2013
Class II · Moderate risk

TriMix Standartd

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 Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-270-2013
Class II · Moderate risk

Pentrexcilina Jarabe NF

Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.

Terminated Labeling / mix-up Opmx, LLC D-300-2013
Class II · Moderate risk

Pentrexcilina

Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.

Terminated Labeling / mix-up Opmx, LLC D-299-2013
Class II · Moderate risk

Zinc Sulfate 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-416-2013
Class II · Moderate risk

Triamcinolone 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-415-2013
Class II · Moderate risk

Thiamine Hydrochloride 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-414-2013
Class II · Moderate risk

Testosterone Cypionate 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-413-2013

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