The Recall Desk
ModerateFDA (Drugs)·D-0516-2021·Announced 2021-06-02

Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 19 bottles of Vitamin D3 25mcg tablets because they were intermittently exposed 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 involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 19 bottles of Vitamin D3 25mcg 180 tablets (NDC/UPC 880681168011) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage.

The affected lots were distributed between February 23, 2021, and March 10, 2021. The product was distributed in Florida, Georgia, and South Carolina. The agency has classified this recall as Class II.

Consumers who have this product should stop using it and contact Cardinal Health Inc. for further instructions or a refund.

The recalled product

Product
VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS
Affected units
19

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)

  • All Lots distributed 02/23/2021 through 03/10/2021.

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 →