Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1865-2019·Announced 2019-09-25

Aurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures

Aurolife Pharma is recalling specific lots of Allergy Relief (Fexofenadine Hydrochloride) 180 mg tablets because they failed impurities and degradation specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) in the absence of reported hospitalizations or serious injuries, as the hazard is a specification failure rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Aurolife Pharma, LLC is recalling Allergy Relief (Fexofenadine Hydrochloride) Tablets USP, 180 mg, distributed by Foodhold U.S.A., LLC. The affected products are packaged in 15-count, 30-count, 45-count bonus, and 45-count cartons under the CAREone brand. The recall involves specific lot numbers with expiration dates of 07/21.

The recall was initiated because the products failed impurities and degradation specifications. This is an FDA Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have purchased these specific lots should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The products were distributed nationwide in the USA.

The recalled product

Product: Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold…
Manufacturer: Aurolife Pharma, LLC
Category: Drug — Antihistamine
Hazard: 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 (5)

Lot #s: a) 067180025D1
Exp 07/21
b) 067180025B1
c) 067180025A1
d) 067180025C1

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Aurolife Pharma, LLC 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 11 products in this recall →

Same manufacturer · Aurolife Pharma, LLC

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Glycopyrrolate Tablets Recalled Due to Glass Pieces in Sealed Bottles
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Severe
Aurolife Recalls Fexofenadine Tablets Due to Impurity Failures
FDA (Drugs) · 2019-09-25
Severe
Aurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures
FDA (Drugs) · 2019-09-25

Same hazard · impurity