The Recall Desk
ModerateFDA (Drugs)·D-0587-2021·Announced 2021-06-02

Cardinal Health Recalls Restora Omega-3 Supplement Due to Temperature Excursions

Cardinal Health Inc. is recalling 31 cartons of Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a storage temperature excursion, which is a quality control issue rather than a direct contamination or acute safety defect like a structural failure or high-risk pathogen.

Plain-English summary

Cardinal Health Inc. is recalling 31 cartons of Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement (NDC 52747-200-30). The product is marketed by US Pharmaceutical Corporation, located in Decatur, Georgia.

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. The product was distributed in Florida, Georgia, and South Carolina.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036
Manufacturer
Cardinal Health Inc.
Category
Drug — Nutritional Supplement
Hazard
Affected units
31

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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