The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0909-2023·Announced 2023-07-19

Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications

L. Perrigo's Allergy Relief 180 mg tablets are being recalled due to failed impurity and degradation specifications. The recall affects 32,904 cartons distributed nationwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a drug recall for failed impurity and degradation specifications with no reported illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not yet been reported qualifies for a score of 3 (High).

Plain-English summary

L. Perrigo Company is recalling Allergy Relief Fexofenadine Hydrochloride Tablets (180 mg) due to failed impurity and degradation specifications. The affected product was distributed nationwide by Publix Super Markets, Inc.

The recall affects 32,904 cartons in two package sizes: 30-count and 45-count cartons. Affected lot numbers include 2CR0652, 2DR0464, and 2DR0465 (expiration 12/23); 2ER0285 (expiration 01/24); 2DR0466 (expiration 12/23); 2ER0412 (expiration 01/24); and 2GR0330 (expiration 04/24).

Consumers who have purchased this product should stop using it and return the cartons to their point of purchase. For questions about your allergy medication, speak with a healthcare provider or pharmacist.

The recalled product

Product
ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Brand
ALLERGY RELIEF
Manufacturer
L. Perrigo Company
Category
Drug — OTC Antihistamine
Hazard
Affected units
32,904

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 (10)

  • Lot #: a) 2CR0652
  • 2DR0464
  • 2DR0465
  • Exp. Date 12/23
  • 2ER0285
  • Exp. Date 01/24. b) 2DR0466
  • 2ER0412
  • Exp. Date 01/24
  • 2GR0330
  • Exp. Date 04/24

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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