The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0503-2021·Announced 2021-06-02

Cardinal Health Recalls Infants Vitamin D Drops Due to Temperature Excursions

Cardinal Health is recalling 422 bottles of Infants Aqueous Vitamin D Oral Drops due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

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 involving temperature excursions. Per the rubric, this falls under moderate severity as it involves a manufacturing deviation without reported illnesses or injuries, and the hazard is theoretical rather than confirmed harm.

Plain-English summary

Cardinal Health Inc. is recalling 422 bottles of Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL. The product was manufactured by Silarx Pharmaceuticals, Inc. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.

The affected lots were distributed between February 23, 2021, and March 10, 2021. Distribution was limited to Florida, Georgia, and South Carolina. The FDA has classified this recall as Class II, indicating a situation in which there is a reasonable probability that the 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 or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA
Manufacturer
Cardinal Health Inc.
Category
Drug — Vitamin Supplement
Hazard
Affected units
422

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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