The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0906-2023·Announced 2023-07-19

OTC Allergy Relief Medication Recalled for Failed Quality Specifications

L. Perrigo Company is recalling approximately 59,688 cartons of Fexofenadine Hydrochloride 180 mg allergy relief tablets nationwide because the product failed to meet FDA specifications for impurities and degradation.

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: FDA Class II classification indicates potential for adverse health consequences, but no illnesses, injuries, hospitalization, or deaths have been reported. The hazard is a product quality issue without known harm to consumers, qualifying this as Moderate (2) rather than Severe (4).

Plain-English summary

L. Perrigo Company is recalling approximately 59,688 cartons of ALLERGY RELIEF Fexofenadine Hydrochloride 180 mg tablets distributed nationwide by Meijer Distribution, Inc. The product is available in three package sizes: 15-count (NDC 79481-0847-0), 30-count (NDC 79481-0847-1), and 45-count (NDC 79481-0847-2).

The recall was initiated because the product failed to meet FDA specifications for impurities and degradation. This is classified as an FDA Class II recall. Affected lot numbers and expiration dates are documented in the official recall notice.

Consumers who have purchased any of the affected lots should discontinue use and contact L. Perrigo Company or Meijer for instructions on return or refund. Any adverse effects experienced should be reported to the FDA's MedWatch program.

The recalled product

Product
ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Brand
ALLERGY RELIEF
Manufacturer
L. Perrigo Company
Category
Drug
Hazard
Affected units
59,688

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 (14)

  • Lot #: a) 2JE1882
  • Exp. date 01/24 b) 2FV1918
  • 2ER0411
  • Exp. date 01/24
  • 2GV1902
  • Exp. date 04/24
  • 2CR0652
  • 2DR0465
  • Exp. date 12/23
  • 2GR0329
  • Exp. date 04/24 c)2CR0653
  • 2DR0466
  • 2ER0287
  • 2ER0412

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by L. Perrigo Company 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 13 products in this recall →

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