The Recall Desk
ModerateFDA (Drugs)·D-1870-2019·Announced 2019-09-25

Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets for Impurity Failures

Aurolife Pharma is recalling specific lots of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.

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: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any specific injuries, illnesses, or fatalities, and the hazard is a failure of impurity specifications rather than a high-risk pathogen or structural defect.

Plain-English summary

Aurolife Pharma, LLC is recalling Fexofenadine Hydrochloride Tablets USP, 180 mg, in 15-count and 30-count cartons. The recall is due to the product failing impurities and degradation specifications. The affected products are distributed by McKesson and sold under the HealthMart Pharmacy brand.

The recall includes 10,992 cartons of the 15-count packaging (NDC 62011-0315-1) and 24,792 cartons of the 30-count packaging (NDC 62011-0315-2). The specific lot numbers and expiration dates are: 067180010B (Exp 03/21), 067180024E1 (Exp 07/21), and 067180016A (Exp 05/21). These products were distributed nationwide in the USA.

Consumers who have these specific lots of Fexofenadine Hydrochloride tablets should stop using them and contact their pharmacist or healthcare provider for guidance on returning the product or obtaining a replacement.

The recalled product

Product
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Antihistamine
Hazard

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 (6)

  • Lot #s: a) 067180010B
  • Exp 03/21
  • 067180024E1
  • Exp 07/21
  • b) 067180016A
  • Exp 05/21

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 →

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