Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Temperature excursions

The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled.

569 FDA drug recalls with this cause, newest first.

Vaccines, insulin, many injectables and some tablets must stay within a narrow temperature band from factory to pharmacy. A truck without working refrigeration, a freezer failure or a warehouse heatwave is enough: the product looks normal but may have lost potency or formed degradation products. FDA files these under 'CGMP deviations' or 'temperature abuse'; we track them separately because the question to ask - how was my medication stored? - is different from every other cause.

Class II · Moderate risk

LEVOXYL Tablets

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. D-0557-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 0069-0471-03 D-0556-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 0069-0469-56 D-0555-2021
Class II · Moderate risk

Chantix (varenicline)

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 0069-0469-03 D-0554-2021
Class II · Moderate risk

Methotrexate Injection

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 61703-350-38 D-0553-2021
Class II · Moderate risk

LYRICA (pregabalin)

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. D-0552-2021
Class II · Moderate risk

Rybelsus (semaglutide)

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 0169-4307-13 D-0536-2021