The Recall Desk
ModerateFDA (Drugs)·D-0515-2021·Announced 2021-06-02

Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 53 bottles of Vitamin D3 25mcg 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 due to a CGMP deviation (temperature excursion) 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 53 bottles of Vitamin D3 25mcg 90 tablets (NDC/UPC 880681168004). The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected lots were distributed between February 23, 2021, and March 10, 2021. The product was distributed in Florida, Georgia, and South Carolina. 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 check their inventory for the specific NDC/UPC and distribution dates. If the product matches the recalled description, consumers should stop using it and contact Cardinal Health Inc. for instructions on return or disposal.

The recalled product

Product
VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS
Manufacturer
Cardinal Health Inc.
Category
Drug — Over-the-Counter Supplements
Hazard
Affected units
53

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 →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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