The Recall Desk
ModerateFDA (Drugs)·D-0357-2022·Announced 2022-01-12

GoodSense Aller.Ease Fexofenadine Recalled for Impurity Specification

Perrigo Company PLC is recalling GoodSense Aller.Ease Fexofenadine hydrochloride 180 mg tablets nationwide due to an out-of-specification impurity detected during stability testing.

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 for a failed specifications issue during stability testing. The source text does not report any illnesses, injuries, or adverse events—only that an impurity specification was not met during testing, making this a precautionary recall without evidence of actual harm.

Plain-English summary

Perrigo Company PLC is recalling GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets (30 count bottles) nationwide. The recall was initiated because an out-of-specification result was obtained for impurity A during stability testing, indicating the product failed established impurity and degradation specifications.

The affected product is Lot # 0MV2158 with an expiration date of 6/1/2022. A total of 3,168 bottles were distributed nationwide in the USA. The product was made in the Czech Republic and distributed by Perrigo Allergan in Michigan.

Consumers in possession of this product should stop use immediately. If you have questions or experience adverse effects, contact your healthcare provider or pharmacist.

The recalled product

Product
GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan MI., 49010, UPC 3 0113 0571 39 3; NDC 0113-0571-30,
Manufacturer
Perrigo Company PLC
Hazard
  • impurity-specification
  • degradation-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 (2)

  • Lot # 0MV2158
  • exp 6/1/2022

Distribution

Distributed nationwide across the United States.