Medications & Supplements/Over-the-Counter

Aurolife Pharma, LLC: Fexofenadine Hydrochloride (Allergy Relief) Recalled for Impurity Issues

Agency Publication Date: September 17, 2019

Summary

Aurolife Pharma is recalling 261,210 units of Fexofenadine Hydrochloride (180 mg), a generic version of the allergy medication Allegra. The recall includes various 180 mg tablet counts sold under brand names like CAREone, Good Neighbor Pharmacy, Member's Mark, sunmark, equate, HealthMart PHARMACY, Wal-Fex, and Discount Drug Mart. The medication is being recalled because it failed specifications for impurities and degradation, which means the drug may not be as safe or effective as intended. These products were distributed nationwide in the USA across multiple major retailers and pharmacies.

Risk

The tablets failed to meet quality standards regarding impurities and degradation products over time. This could potentially lead to reduced effectiveness of the allergy medication or exposure to unintended chemical byproducts, though no specific adverse events have been reported to date.

What You Should Do

Check your medication packaging for the product name 'Fexofenadine Hydrochloride' or 'Allergy Relief' and the dosage '180 mg'.
Verify if your bottle or carton matches the specific brand and lot numbers, such as Member's Mark 150-count (Lots 067180009A, 067180013A, 067180014A, 067180015A, 067180018A, 067180020A, 067180021A1, 067180022A1, 06718028A1, 06718028B1, 06719001A3) or equate 15-count (Lots 067180010A, 067180023C1, 067180024D1).
Confirm the UPC and NDC codes on the packaging, such as Member's Mark UPC 0 78742 23550 9 (NDC 68196-976-91) or Wal-Fex NDC 0363-0097-55.
If your product is affected, contact your healthcare provider or pharmacist for guidance on an alternative allergy treatment.
Return any unused portion of the recalled medication to the pharmacy or retail store where it was purchased for a full refund.
Contact Aurolife Pharma, LLC or the distributor listed on your packaging for further instructions regarding the return process.
For general questions about the recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist and return for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fexofenadine Hydrochrloride Tablets USP, 180 mg (100-count bottle)

Model:

NDC 58602-711-21

Lot Numbers:

067180008A (Exp 03/21)

Product: CAREone Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg (15, 30, 45-count)

Model:

NDC 60000-409-53

NDC 60000-409-30

NDC 60000-409-48

NDC 60000-409-45

Lot Numbers:

067180025D1 (Exp 07/21)

067180025B1 (Exp 07/21)

067180025A1 (Exp 07/21)

067180025C1 (Exp 07/21)

Product: Good Neighbor Pharmacy Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg (5-count)

Model:

NDC 46122-387-23

Lot Numbers:

067180024A1 (Exp 07/21)

Product: Member's Mark fexofenadine hydrochloride tablets USP, 180 mg (150-count bottle)

Model:

NDC 68196-976-91

UPC Codes:

078742235509

Lot Numbers:

067180009A (Exp 03/21)

067180013A (Exp 04/21)

067180014A (Exp 04/21)

067180015A (Exp 04/21)

067180018A (Exp 05/21)

067180020A (Exp 06/21)

067180021A1 (Exp 07/21)

067180022A1 (Exp 07/21)

06718028A1 (Exp 09/21)

06718028B1 (Exp 09/21)

06719001A3 (Exp 01/22)

Product: sunmark Fexofenadine Hydrochloride Tablets USP, 180 mg (15, 30-count)

Model:

NDC 70677-0008-2

NDC 70677-0008-1

Lot Numbers:

067180016B (Exp 05/21)

067180024F1 (Exp 07/21)

Product: equate Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg (15-count)

Model:

NDC 49035-995-62

Lot Numbers:

067180010A (Exp 03/21)

067180023C1 (Exp 07/21)

067180024D1 (Exp 07/21)

Product: HealthMart PHARMACY Fexofenadine Hydrochloride Tablets USP, 180 mg (15, 30-count)

Model:

NDC 62011-0315-1

NDC 62011-0315-2

Lot Numbers:

067180010B (Exp 03/21)

067180024E1 (Exp 07/21)

067180016A (Exp 05/21)

Product: Aurohealth LLC Fexofenadine HCL Tablets USP, 180 mg (500-count BRITE STOCK)

Lot Numbers:

067180011A (Exp 04/21)

067180012A (Exp 04/21)

06718027B1 (Exp 09/21)

Product: Aurohealth LLC Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg (30-count bottle)

Model:

NDC 58602-820-09

Lot Numbers:

067180026A1 (Exp 07/21)

Product: Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg (5-count)

Model:

NDC 0363-0097-55

Lot Numbers:

06718027A1 (Exp 09/21)

Product: Discount Drug Mart Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg (30-count)

Model:

NDC 53943-021-09

Lot Numbers:

067180024B1 (Exp 07/21)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83581

Status: Resolved

Manufacturer: Aurolife Pharma, LLC

Sold By: Aurohealth LLC; Foodhold U.S.A., LLC; Amerisource Bergen; Sam's West, Inc.; McKesson; Wal-Mart Stores, Inc.; Walgreen Co.; Discount Drug Mart; CAREone; Good Neighbor Pharmacy; HealthMart PHARMACY; Member's Mark; sunmark; equate

Manufactured In: United States

Units Affected: 11 products (8,240 bottles; a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons; 3240 cartons; 71,748 bottles; a) 11,928 cartons; b) 288 cartons; 129,600 cartons; a) 10,992 cartons; b) 24,792 cartons; 6104 bottles; 240 bottles; 4920 cartons; 4536 cartons)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging for the product name 'Fexofenadine Hydrochloride' or 'Allergy Relief' and the dosage '180 mg'.

Verify if your bottle or carton matches the specific brand and lot numbers, such as Member's Mark 150-count (Lots 067180009A, 067180013A, 067180014A, 067180015A, 067180018A, 067180020A, 067180021A1, 067180022A1, 06718028A1, 06718028B1, 06719001A3) or equate 15-count (Lots 067180010A, 067180023C1, 067180024D1).

Confirm the UPC and NDC codes on the packaging, such as Member's Mark UPC 0 78742 23550 9 (NDC 68196-976-91) or Wal-Fex NDC 0363-0097-55.

If your product is affected, contact your healthcare provider or pharmacist for guidance on an alternative allergy treatment.

Return any unused portion of the recalled medication to the pharmacy or retail store where it was purchased for a full refund.

Contact Aurolife Pharma, LLC or the distributor listed on your packaging for further instructions regarding the return process.

For general questions about the recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Fexofenadine Hydrochrloride Tablets USP, 180 mg (100-count bottle)

Model:

NDC 58602-711-21

Lot Numbers:

067180008A (Exp 03/21)

Product: CAREone Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg (15, 30, 45-count)

Model:

NDC 60000-409-53

NDC 60000-409-30

NDC 60000-409-48

NDC 60000-409-45

Lot Numbers:

067180025D1 (Exp 07/21)

067180025B1 (Exp 07/21)

067180025A1 (Exp 07/21)

067180025C1 (Exp 07/21)

Product: Good Neighbor Pharmacy Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg (5-count)

Model:

NDC 46122-387-23

Lot Numbers:

067180024A1 (Exp 07/21)

Product: Member's Mark fexofenadine hydrochloride tablets USP, 180 mg (150-count bottle)

Model:

NDC 68196-976-91

UPC Codes:

078742235509

Lot Numbers:

067180009A (Exp 03/21)

067180013A (Exp 04/21)

067180014A (Exp 04/21)

067180015A (Exp 04/21)

067180018A (Exp 05/21)

067180020A (Exp 06/21)

067180021A1 (Exp 07/21)

067180022A1 (Exp 07/21)

06718028A1 (Exp 09/21)

06718028B1 (Exp 09/21)

06719001A3 (Exp 01/22)

Product: sunmark Fexofenadine Hydrochloride Tablets USP, 180 mg (15, 30-count)

Model:

NDC 70677-0008-2

NDC 70677-0008-1

Lot Numbers:

067180016B (Exp 05/21)

067180024F1 (Exp 07/21)

Product: equate Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg (15-count)

Model:

NDC 49035-995-62

Lot Numbers:

067180010A (Exp 03/21)

067180023C1 (Exp 07/21)

067180024D1 (Exp 07/21)

Product: HealthMart PHARMACY Fexofenadine Hydrochloride Tablets USP, 180 mg (15, 30-count)

Model:

NDC 62011-0315-1

NDC 62011-0315-2

Lot Numbers:

067180010B (Exp 03/21)

067180024E1 (Exp 07/21)

067180016A (Exp 05/21)

Product: Aurohealth LLC Fexofenadine HCL Tablets USP, 180 mg (500-count BRITE STOCK)

Lot Numbers:

067180011A (Exp 04/21)

067180012A (Exp 04/21)

06718027B1 (Exp 09/21)

Product: Aurohealth LLC Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg (30-count bottle)

Model:

NDC 58602-820-09

Lot Numbers:

067180026A1 (Exp 07/21)

Product: Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg (5-count)

Model:

NDC 0363-0097-55

Lot Numbers:

06718027A1 (Exp 09/21)

Product: Discount Drug Mart Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg (30-count)

Model:

NDC 53943-021-09

Lot Numbers:

067180024B1 (Exp 07/21)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83581

Status: Resolved

Manufacturer: Aurolife Pharma, LLC

Manufactured In: United States

Distributed To: Nationwide