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

Ferrous Sulfate 75 mg

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 54838-011-50 D-0504-2021
Class II · Moderate risk

Livalo (pitavastatin)

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 66869-204-90 D-0500-2021
Class II · Moderate risk

Auryxia (ferric citrate)

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 59922-631-01 D-0499-2021
Class II · Moderate risk

Leucovorin 15mg 24

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. D-0493-2021
Class II · Moderate risk

AcetaZOLAMIDE Tablets

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 23155-287-01 D-0490-2021
Class II · Moderate risk

FaBB Vitamin B6

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. D-0488-2021
Class II · Moderate risk

Theophylline

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 68462-380-01 D-0485-2021

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