The Recall Desk
ModerateFDA (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.

What this means for you

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 Re
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine / Allergy Relief
Hazard
  • impurity-degradation
  • failed-specification

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.

Related recalls

Same category