The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1864-2019·Announced 2019-09-25

Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

Aurolife Pharma is recalling 8,240 bottles of Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving structural or chemical specification failures like impurities.

Plain-English summary

Aurolife Pharma, LLC is recalling 8,240 bottles of Fexofenadine Hydrochloride Tablets USP, 180 mg, 100-count bottles. The product is distributed by Aurohealth LLC and carries the NDC 58602-711-21. The specific lot number is 067180008A with an expiration date of 03/21.

The recall was initiated because the product failed impurities and degradation specifications. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide in the USA. Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Antihistamine
Hazard
Affected units
8,240

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 #: 067180008A
  • Exp 03/21

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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