The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0334-2022·Announced 2022-01-12

CAREONE Allergy Relief 180 mg Tablets Recalled for Failed Impurities Specifications

Perrigo Company PLC is recalling CAREONE Allergy Relief (Fexofenadine HCL) 180 mg tablets nationwide because stability testing found impurity A out of specification.

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 with no reported illness or injury. The hazard is chemical degradation/impurity formation detected during stability testing, a quality control issue with theoretical rather than documented harm, placing this in the Moderate category per the rubric.

Plain-English summary

Perrigo Company PLC is recalling CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets 180 mg, an over-the-counter antihistamine. The recall affects 28,776 containers distributed nationwide in the USA.

The FDA Class II recall was issued because stability testing results showed impurity A levels that exceeded specification limits. This indicates degradation of the active ingredient or formation of unwanted compounds during the product's shelf life.

Affected products are sold in 30-count bottles (NDC 41520-229-39) and 45-count bottles (NDC 41520-229-95). Specific affected lot numbers and expiration dates are: Lot 0FR0459 (Exp 2/28/2022), Lot 0LR0362 (Exp 6/30/2022), Lot 1BR0462 (Exp 10/31/2022), and Lot 0LR0363 (Exp 6/30/2022). The product was made in the Czech Republic and distributed by Foodhold U.S.A. LLC of Landover, MD.

Consumers who have purchased affected CAREONE Allergy Relief should stop use and dispose of the product or return it to the place of purchase.

The recalled product

Product
CAREONE ALLERGY RELIEF (FEXOFENADINE HCL)
Brand
CAREONE ALLERGY RELIEF
Manufacturer
Perrigo Company PLC
Category
Drug — OTC Antihistamine
Hazard
Affected units
28,776

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 (6)

  • Lot a) 0FR0459
  • Exp 2/28/2022
  • 0LR0362
  • Exp 6/30/2022
  • 1BR0462
  • Exp 10/31/2022 b) 0LR0363

UPCs (2)

  • 341520319846
  • 341520319839

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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