Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0351-2022·Announced 2022-01-12

Up&Up Allergy Relief 180mg Tablets Recalled for Failed Impurity Specification

Perrigo Company PLC is recalling up&up allergy relief fexofenadine hydrochloride 180mg tablets distributed nationwide because stability testing found impurity A exceeded specifications. The affected products are 15-count and 30-count bottles with specific lot numbers and expiration dates.

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. The source text states only that impurity specifications were failed during stability testing with no reported illnesses or injuries. There is no indication of known harm or high-risk contamination. This qualifies as a moderate precautionary recall based on the failed specifications and Class II classification.

Plain-English summary

Perrigo Company PLC is recalling up&up allergy relief, fexofenadine hydrochloride tablets, 24-hour, 180mg antihistamine. The recall involves approximately 7,272 containers distributed nationwide in the USA. The products were made in the Czech Republic and distributed by Target Corp. (Minneapolis, MN).

The recall was initiated because stability testing found that impurity A in the tablets did not meet specification requirements. Specifically, an out-of-specification result for impurity A was obtained during stability testing.

Two packaging configurations are affected: (a) 15-count bottles with lot number 1AE2334, expiration 02/28/2022, NDC 11673-571-22, UPC 3 70030 62303 7; and (b) 30-count bottles with lot number 1BR0462, expiration 10/31/2022, NDC 11673-571-39, UPC 3 70030 62301 3.

Consumers who have purchased these products should stop using them and consult their healthcare provider if they have questions or concerns.

The recalled product

Product: up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 count bottle, NDC 11673-571-22 UPC 3 70030 62303 7; b) 30 count bottle, NDC 11673-571-39 UPC 3 70030 62301 3; Distributed by Target Corp., Mpls., MN 55403, Made in the Czech…
Manufacturer: Perrigo Company PLC
Category: Drug — Antihistamine / Allergy Relief
Hazard: impurity-degradation
failed-specification
Affected units: 7,272

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 (4)

Lot a) 1AE2334
Exp 02/28/2022
b) 1BR0462
Exp 10/31/2022

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 →

Same manufacturer · Perrigo Company PLC

See all →

Moderate
CareOne Severe Congestion Nasal Spray Recalled Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
Moderate
Equate Children's Pain and Fever Acetaminophen Suspension Recall
FDA (Drugs) · 2022-03-02
Moderate
Equaline Nasal Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
Moderate
UP AND UP Childrens Acetaminophen Recall Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
Moderate
CVS Infant's Grape Acetaminophen Suspension Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02

Same hazard · impurity degradation