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

Sulindac Tablets

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 42806-011-01 D-0582-2021
Class II · Moderate risk

Balziva 28 Day

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 0555-9034-58 D-0579-2021
Class II · Moderate risk

Proair HFA

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 59310-579-22 D-0573-2021
Class II · Moderate risk

Trokendi XR

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 17772-103-30 D-0570-2021
Class II · Moderate risk

Cefazolin for Injection

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 0781-3451-70 D-0564-2021

Recalls by year