Aurolife Pharma Fexofenadine Hydrochrloride Tablets Recall

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21

Lot numbers, UPCs & expiration codes

Lot #: 067180008A, Exp 03/21

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1864-2019
Classification: Class II
Status: Terminated
Recall initiated: Aug 23, 2019
FDA report date: Sep 25, 2019
Quantity: 8,240 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Aurolife Pharma, LLC

Original FDA data

Every field from FDA enforcement report D-1864-2019, exactly as published.

Show all FDA fields

City: Dayton
State: NJ
Status: Terminated
Country: United States
Event ID: 83581
Address: 2400 US Highway 130
Code information: Lot #: 067180008A, Exp 03/21
Postal code: 08810-1519
Report date: Sep 25, 2019
Product type: Drugs
Recall number: D-1864-2019
Classification: Class II
Recalling firm: Aurolife Pharma, LLC
Product quantity: 8,240 bottles
Termination date: Aug 16, 2022
Reason for recall: Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
Distribution pattern: Nationwide in the USA
Recall initiation date: Aug 23, 2019
Initial firm notification: Letter
Center classification date: Sep 17, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1864-2019, published Sep 25, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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