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

Kali Sulphuricum 3X

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0871-2021
Class II · Moderate risk

La Core LCL-2-0191 Blend

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0870-2021
Class II · Moderate risk

Viola Odorata 4X

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0869-2021
Class II · Moderate risk

Verbena Officinalis 6X

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0868-2021
Class II · Moderate risk

Quebracho 4C

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0867-2021
Class II · Moderate risk

Humulus 6X

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0866-2021
Class II · Moderate risk

Cistus Canadensis 6X

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0865-2021
Class II · Moderate risk

Cinnamomum 6X

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0864-2021
Class II · Moderate risk

Althaea Officinalis 4X

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0863-2021
Class II · Moderate risk

Cedar Fever Drops

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0862-2021
Class II · Moderate risk

Haloderm Homeopathic Blend

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0861-2021
Class II · Moderate risk

Yeast Guard Blend

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Terminated Failed specification Washington Homeopathic Products, Inc. D-0860-2021
Class II · Moderate risk

Trulicity (dulaglutide)

Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.

Terminated Labeling / mix-up Eli Lilly & Company NDC 0002-1433-80 D-0773-2021
Class II · Moderate risk

Carvedilol 25 mg

A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

Terminated Other RemedyRepack Inc. NDC 68382-0095-05 D-0754-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Ongoing Nitrosamine impurity Pfizer Inc. NDC 0069-0469-03 D-0811-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Ongoing Nitrosamine impurity Pfizer Inc. NDC 0069-0469-56 D-0810-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Ongoing Nitrosamine impurity Pfizer Inc. NDC 0069-0468-56 D-0809-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Ongoing Nitrosamine impurity Pfizer Inc. NDC 00069-0471-03 D-0808-2021
Class II · Moderate risk

Sodium Phenylbutyrate POWDER

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

Terminated Impurity / degradation SigmaPharm Laboratories LLC NDC 42794-086-14 D-0766-2021

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