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.

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Medroxyprogesterone Acetate Injectable Suspension

Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.

Ongoing Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office NDC 55150-0330-01 D-0400-2025
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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