The Recall Desk
ModerateFDA (Drugs)·D-0536-2021·Announced 2021-06-02

Cardinal Health Recalls Ozempic Tablets Due to Temperature Excursions

Cardinal Health is recalling 1,189 cartons of Ozempic (oral semaglutide) tablets due to intermittent exposure to temperature excursions during storage.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves storage conditions (temperature excursions) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Cardinal Health Inc. is recalling 1,189 cartons of Ozempic (oral semaglutide) tablets. The recall is due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product is Rybelsus (semaglutide) Tablets 7 mg, NDC 0169-4307-13, with code K082347. The product was distributed in Florida, Georgia, and South Carolina.

Consumers should check their medication for the specific NDC and code listed above. If the product matches the description, they should contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
OZEMPIC (ORAL SEMAGLUTIDE)
Brand
OZEMPIC
Affected units
1,189

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • K082347

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 198 products in this recall →