Cardinal Health Recalls Cetirizine Hydrochloride Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 1,371 bottles of Cetirizine Hydrochloride Tablets, 10 mg, 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 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 1,371 bottles of Cetirizine Hydrochloride Tablets, 10 mg, 300 Count (NDC/UPC 345802919878). The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. All lots were distributed between February 23, 2021, and March 10, 2021.
Consumers who have this product should stop using it and contact Cardinal Health Inc. for a refund or replacement. The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS
- Manufacturer
- Cardinal Health Inc.
- Affected units
- 1,371
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
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.
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