The Recall Desk
ModerateFDA (Drugs)·D-0519-2021·Announced 2021-06-02

Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

Cardinal Health is recalling Vitamin D3 50mcg tablets due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

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 due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 427 bottles of Vitamin D3 50mcg tablets (NDC/UPC 880681170007). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. All lots were distributed between February 23, 2021, and March 10, 2021. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased this product should stop using it and contact Cardinal Health Inc. for further instructions or a refund. The recall is limited to the specific NDC/UPC and distribution dates listed above.

The recalled product

Product
VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS
Affected units
427

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 →