The Recall Desk
HighFDA (Drugs)·D-0907-2023·Announced 2023-07-19

Fexofenadine Hydrochloride Tablets Recalled for Failed Purity Specifications

L. Perrigo Company is recalling 15,504 cartons of Fexofenadine Hydrochloride 180 mg tablets nationwide due to failed impurity and degradation specifications.

What this means for you

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 an FDA Class II recall involving failed chemical purity and degradation specifications in an over-the-counter medication. No illnesses or injuries have been reported, and the hazard is based on failed quality testing rather than confirmed harm.

Plain-English summary

L. Perrigo Company is recalling 15,504 cartons of Fexofenadine Hydrochloride 180 mg tablets nationwide in the United States. The affected product is identified by NDC 45802-847-78, Lot #2DR0351, with an expiration date of 12/23.

The recall was initiated because the product failed to meet impurity and degradation specifications. These specifications ensure the chemical purity and stability of the drug.

This recall affects consumers nationwide who obtained these tablets from retail locations. Fexofenadine Hydrochloride is an over-the-counter antihistamine used to treat allergy symptoms.

Consumers who have purchased this product should discontinue use and return it to their pharmacy. Healthcare providers and patients should contact Perrigo or the FDA with any questions about this recall.

The recalled product

Product
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
Brand
FEXOFENADINE HYDROCHLORIDE
Manufacturer
L. Perrigo Company
Hazard
  • chemical-impurity
  • degradation

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 #: 2DR0351
  • Exp. date 12/23

Distribution

Distributed nationwide across the United States.

Same brand · FEXOFENADINE HYDROCHLORIDE