The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0514-2021·Announced 2021-06-02

Cardinal Health Recalls Vitamin D3 Softgels Due to Storage Temperature Excursions

Cardinal Health is recalling Vitamin D3 50mcg softgels due to intermittent exposure to temperature excursions during storage.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 380 bottles of Vitamin D3 50mcg 100 Softgels (NDC/UPC 880681009000). The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed to Florida, Georgia, and South Carolina between February 23, 2021, and March 10, 2021. The FDA has classified this recall as Class II, indicating a situation that could cause temporary or medically reversible adverse health consequences.

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 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP
Manufacturer
Cardinal Health Inc.
Category
Drug — Over-the-Counter Supplement
Hazard
Affected units
380

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 →

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