The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0547-2021·Announced 2021-06-02

Cardinal Health Recalls Loratadine Tablets Due to Temperature Excursions

Cardinal Health is recalling 2,854 bottles of Loratadine 10mg tablets distributed in Florida, Georgia, and South Carolina due to intermittent 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 involving temperature excursions. As no specific illnesses or injuries are reported and the hazard is related to storage conditions rather than a high-risk pathogen or structural defect, it fits the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 2,854 bottles of Loratadine 10mg tablets (NDC/UPC 34580-2650-788). The product is an over-the-counter medication available in tablet form. 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. 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. or their healthcare provider for further instructions on how to return the product or obtain a replacement.

The recalled product

Product
LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS
Manufacturer
Cardinal Health Inc.
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
2,854

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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