The Recall Desk
SevereFDA (Drugs)·D-1871-2019·Announced 2019-09-25

Aurolife Pharma Recalls Fexofenadine HCL Tablets Due to Impurity Failures

Aurolife Pharma is recalling 6,104 bottles of Fexofenadine HCL 180 mg tablets because they failed impurity and degradation specifications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Aurolife Pharma, LLC is recalling 6,104 bottles of Fexofenadine HCL Tablets USP, 180 mg. The product was manufactured for Aurohealth LLC and distributed nationwide in the USA. The recall was initiated because the tablets failed to meet impurities and degradation specifications.

The affected lots are 067180011A (Exp 04/21), 067180012A (Exp 04/21), and 06718027B1 (Exp 09/21). The FDA has classified this recall as Class II, which indicates 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 these specific lots of Fexofenadine HCL tablets should stop using them and contact their pharmacist or healthcare provider for further instructions. The recall is limited to the specific lot numbers and expiration dates listed above.

The recalled product

Product
Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Prescription Medication
Hazard
Affected units
6,104

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:067180011A
  • 067180012A
  • Exp 04/21
  • 06718027B1
  • Exp 09/21

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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