Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

40 recalls, newest first

Class II · Moderate risk

Lisdexamfetamine Dimesylate Capsules

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

Terminated Labeling / mix-up Lannett Company Inc. NDC 0527-4664-37 D-0599-2025
Class II · Moderate risk

clomiPRAMINE Hydrochloride Capsules USP 25 mg

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

Terminated Impurity / degradation Lupin Pharmaceuticals Inc. NDC 68180-492-01 D-0537-2025
Class II · Moderate risk

Nature Mint

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-05 D-0440-2025
Class II · Moderate risk

Nature Mint

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-07 D-0437-2025
Class II · Moderate risk

Nature Mint

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-02 D-0436-2025
Class II · Moderate risk

Nature Mint

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-131-06 D-0435-2025
Class II · Moderate risk

Maximum Security

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-132-04 D-0434-2025
Class II · Moderate risk

Maximum Security

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-132-01 D-0433-2025
Class II · Moderate risk

Maximum Security

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 53247-132-03 D-0432-2025
Class II · Moderate risk

Rapidol

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 55758-440-02 D-0429-2025
Class II · Moderate risk

Optim V

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 55758-300-01 D-0427-2025
Class II · Moderate risk

Kofal

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 55758-109-02 D-0426-2025
Class II · Moderate risk

KOFAL Original

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 55758-106-04 D-0425-2025
Class II · Moderate risk

Kingskin

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited NDC 55758-423-15 D-0424-2025
Class II · Moderate risk

Cura Hongos

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited D-0423-2025
Class II · Moderate risk

Cura Hongos

CGMP Deviations

Terminated cGMP deviation Kenil Healthcare Private Limited D-0422-2025

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