The Recall Desk
ModerateFDA (Drugs)·D-0548-2021·Announced 2021-06-02

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.

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 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.
Category
Drug — Over-the-Counter Medication
Hazard
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

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.

See all →

Same hazard · temperature excursion

See all →