The Recall Desk
HighFDA (Drugs)·D-0902-2023·Announced 2023-07-19

Careone Allergy Relief tablets recalled for failed impurity and degradation specifications

Careone Allergy Relief fexofenadine hydrochloride 180mg tablets are recalled nationwide for failing impurity and degradation specifications. Lot 2JE2185 with expiration date 01/24 is affected.

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: FDA Class II recall involving failed pharmaceutical quality specifications (impurities and degradation) constitutes a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for severity score 3.

Plain-English summary

Careone Allergy Relief fexofenadine hydrochloride 180mg tablets are being recalled due to failed impurity and degradation testing specifications. The affected product is a 15-count carton distributed by Adusa Distribution, LLC in Salisbury, North Carolina.

The manufacturer, L. Perrigo Company, initiated this recall after determining that certain lots failed to meet established specifications for impurities and product degradation. This is classified as a Class II recall by the FDA.

The recall affects 3,240 cartons distributed nationwide within the United States. Lot 2JE2185 with expiration date 01/24 is specifically identified as part of this recall.

The recalled product

Product
CAREONE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Brand
CAREONE ALLERGY RELIEF
Manufacturer
L. Perrigo Company
Category
Drug
Hazard
Affected units
3,240

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 #: 2JE2185
  • Exp. date 01/24

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by L. Perrigo Company 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 13 products in this recall →

Related recalls

Same brand · CAREONE ALLERGY RELIEF

Same manufacturer · L. Perrigo Company

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Same hazard · impurity

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