Independent register of U.S. FDA drug recalls · updated Oct 13, 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.

14,543 recalls, newest first.

Class II · Moderate risk

Repaskin 30

cGMP Deviations; product does not comply with cGMP requirements

Ongoing cGMP deviation Sesderma, SL NDC 63181-0010-1 D-0849-2016
Class II · Moderate risk

Repaskin 50

cGMP Deviations; product does not comply with cGMP requirements

Ongoing cGMP deviation Sesderma, SL NDC 63181-0011-1 D-0848-2016
Class II · Moderate risk

Repaskin 30

cGMP Deviations; product does not comply with cGMP requirements

Ongoing cGMP deviation Sesderma, SL NDC 63181-0012-1 D-0845-2016
Class II · Moderate risk

Repaskin 50

cGMP Deviations; product does not comply with cGMP requirements

Ongoing cGMP deviation Sesderma, SL NDC 63181-0013-1 D-0844-2016
Class II · Moderate risk

Testosterone USP 99.5%

Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination Qualgen NDC 69761-125-01 D-0387-2016
Class II · Moderate risk

Estradiol USP 99.5%

Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination Qualgen NDC 69761-006-01 D-0386-2016
Class II · Moderate risk

PGE 25mcg/ml

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination Pacific Healthcare, Inc dba B&B Pharmacy D-0180-2016
Class II · Moderate risk

Papa/Pge1/Phento

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination Pacific Healthcare, Inc dba B&B Pharmacy D-0179-2016
Class II · Moderate risk

Papa/Phento

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination Pacific Healthcare, Inc dba B&B Pharmacy D-0178-2016
Class II · Moderate risk

PGE 30mcg/ml Injection

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination Pacific Healthcare, Inc dba B&B Pharmacy D-0177-2016
Class II · Moderate risk

Papa/Pge1/Phento

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination Pacific Healthcare, Inc dba B&B Pharmacy D-0176-2016

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