The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0346-2022·Announced 2022-01-12

Perrigo Fexofenadine Hydrochloride Tablets Recall for Impurity Contamination

Perrigo Company PLC is recalling Fexofenadine Hydrochloride 60mg antihistamine tablets (100-count bottles) nationwide due to failed impurity specifications found during stability testing. The recall affects 41,472 containers distributed in the USA.

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: This is an FDA Class II recall involving failed impurity/degradation specifications discovered during stability testing. No illnesses or injuries are reported in the source text, and the hazard is quality-control based rather than involving known pathogens or acute health risks, placing it in the Moderate category.

Plain-English summary

Perrigo Company PLC is recalling Fexofenadine Hydrochloride tablets, 12-hour formulation, 60mg antihistamine strength, sold in 100-count bottles, manufactured in the Czech Republic and distributed by Perrigo in Michigan. The recall involves 41,472 containers distributed nationwide in the USA.

The recall was initiated because out-of-specification results for impurity A were obtained during stability testing, indicating the product failed to meet established purity standards.

Affected lots are: Lot# 0CR0510 (expiration 09/30/21), 0GR0445 (expiration 01/31/22), 0LR0361 (expiration 04/30/22), and 1AR0558 (expiration 07/31/22). The product identifiers are NDC 45802-425-78 and UPC 3 45802 425 78 2.

Consumers should stop using the recalled product and contact their pharmacist or healthcare provider with questions.

The recalled product

Product
Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine / Allergy Medication
Hazard
Affected units
41,472

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 (8)

  • Lot# 0CR0510
  • Exp 09/30/21
  • 0GR0445
  • Exp 01/31/22
  • 0LR0361
  • Exp 04/30/22
  • 1AR0558
  • Exp 07/31/22

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 recalled by Perrigo Company PLC 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 30 products in this recall →

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