The Recall Desk
ModerateFDA (Drugs)·D-0336-2022·Announced 2022-01-12

DG/health Aller.Ease Fexofenadine Tablets Recalled for Impurity

Perrigo Company PLC is recalling DG/health Aller.Ease Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity specifications 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. The source text does not report any illnesses, injuries, or adverse events; the hazard is based on failed specifications during stability testing. No reported harm exists, making this a moderate-severity precautionary recall.

Plain-English summary

Perrigo Company PLC is recalling DG/health Aller.Ease Fexofenadine Hydrochloride Tablets, 180 mg, 10-count bottles distributed nationwide in the USA. The recall was initiated because an out-of-specification result was obtained for impurity A during stability testing.

The affected product was made in Czech Republic and distributed by Dolgencorp, LLC. The recall involves lot numbers 0KE2979 and 0ME2088, with expiration date 2/28/2022. A total of 24,912 containers were distributed.

Consumers who have purchased this product should discontinue use and consult with their healthcare provider or pharmacist regarding alternative treatments for allergies. Consumers may return the product to the place of purchase for a refund or exchange.

The recalled product

Product
DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7
Manufacturer
Perrigo Company PLC
Hazard
  • impurity-degradation
  • out-of-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 (3)

  • Lot 0KE2979
  • 0ME2088
  • Exp 2/28/2022

Distribution

Distributed nationwide across the United States.