The Recall Desk
ModerateFDA (Drugs)·D-0546-2021·Announced 2021-06-02

Cardinal Health Recalls Fexofenadine Tablets Due to Temperature Excursions

Cardinal Health is recalling 321 bottles of Fexofenadine Hydrochloride 180 mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

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 involving temperature excursions, which is a low-risk contamination or labeling issue without reported illness, fitting the Moderate severity criteria.

Plain-English summary

Cardinal Health Inc. is recalling 321 bottles of Fexofenadine Hydrochloride Tablets, 180 mg, NDC 45802-571-78. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.

The affected product was distributed by Perrigo in Allegan, Michigan, to locations 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 their healthcare provider or pharmacist for guidance. 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.

The recalled product

Product
Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010
Manufacturer
Cardinal Health Inc.
Category
Drug — Antihistamine
Hazard
Affected units
321

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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