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Thousands of Antihistamines Recalled


September 27, 2019

Aurolife Pharma is recalling fexofenadine hydrochloride tablets distributed by multiple outlets under a variety of brands throughout the United States. According to the September 25, 2019, US Food and Drug Administration (FDA) Enforcement Report, the tablets failed to meet impurity/degradation specifications. 

The following products are being recalled:

  • Fexofenadine Hydrochloride Tablets USP, 180 mg, 100-count bottles (NDC 58602-711-21), distributed by Aurohealth, from lot 067180008A (Exp. 3/21); 
  • Allergy Relief (fexofenadine hydrochloride) Tablets USP, 180 mg, 15-count cartons (NDC 60000-409-53), CareOne, distributed by Foodhold USA, from lot 067180025D1 (Exp. 7/21); 
  • Allergy Relief (fexofenadine hydrochloride) Tablets USP, 180 mg, 30-count cartons (NDC 60000-409-30), CareOne, distributed by Foodhold USA, from lot 067180025B1 (Exp. 7/21); 
  • Allergy Relief (fexofenadine hydrochloride) Tablets USP, 180 mg, 45-count bonus cartons (NDC 60000-409-48), CareOne, distributed by Foodhold USA, from lot 067180025A1 (Exp. 7/21); 
  • Allergy Relief (fexofenadine hydrochloride) Tablets USP, 180 mg, 45-count cartons (NDC 60000-409-45), CareOne, distributed by Foodhold USA, from lot 067180025C1 (Exp. 7/21);
  • Allergy Relief (fexofenadine hydrochloride) Tablets, 180 mg, 5-count cartons (NDC 46122-387-23), Good Neighbor Pharmacy, distributed by Amerisource Bergen, from lot 067180024A1 (Exp. 7/21); 
  • Fexofenadine Hydrochloride Tablets USP, 180 mg, 150-count bottles (NDC 68196-976-91, UPC 0 78742 23550 9), Member's Mark, distributed by Sam's West Inc., from lots 067180009A (Exp. 3/21), 067180013A, 067180014A, and 067180015A (Exp. 4/21), 067180018A (Exp. 5/21), 067180020A (Exp. 6/21), 067180021A1 and 067180022A1 (Exp. 7/21), 06718028A1 and 06718028B1 (Exp. 9/21), and 06719001A3 (Exp. 1/22);
  • Fexofenadine Hydrochloride Tablets USP, 180 mg, 30-count cartons (NDC 70677-0008-2), Sunmark, distributed by McKesson, from lot 067180016B (Exp. 5/21);
  • Fexofenadine Hydrochloride Tablets USP, 180 mg, 15-count cartons (NDC 70677-0008-1), Sunmark, distributed by McKesson, from lot 067180024F1 (Exp. 7/21); 
  • Allergy Relief (fexofenadine HCl) Tablets USP, 180 mg, 15-count cartons (NDC 49035-995-62), Equate, distributed by Wal-Mart Stores Inc., from lots 067180010A (Exp. 3/21), 067180023C1 (Exp. 7/21), and 067180024D1 (Exp. 7/21); 
  • Fexofenadine Hydrochloride Tablets USP, 180 mg, in 15-count cartons (NDC 62011-0315-1), HealthMart Pharmacy, distributed by McKesson, from lots 067180010B (Exp. 3/21) and 067180024E1 (Exp. 7/21); 
  • Fexofenadine Hydrochloride Tablets USP, 180 mg, in 30-count cartons (NDC 62011-0315-2), HealthMart Pharmacy, distributed by McKesson, from lot 067180016A (Exp. 5/21); 
  • Allergy (fexofenadine hydrochloride) Tablets USP, 180 mg, 30-count bottles (NDC 58602-820-09), distributed by Aurohealth, from lot 067180026A1 (Exp. 7/21); 
  • Allergy (fexofenadine hydrochloride) Tablets USP, 180 mg, 30-count cartons (NDC 53943-021-09), Discount Drug Mart Food Fair, distributed by Discount Drug Mart, from lot 067180024B1 (Exp. 7/21);
  • Wal-Fex (fexofenadine hydrochloride) Tablets USP, 180 mg, 5-count cartons (NDC 0363-0097-55), distributed by Walgreen Co., from lot 06718027A1 (Exp. 9/21); and 
  • Fexofenadine HCL Tablets USP, 180 mg, 500's Brite Stock, manufactured for Aurohealth by Aurolife Pharma, from lots 067180011A (Exp. 4/21), 067180012A (Exp. 4/21), and 06718027B1 (Exp. 9/21).

Aurolife Pharma voluntarily initiated the recall August 28, 2019. On September 17, 2019, the FDA designated it Class II. The recall classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists. 

Fexofenadine hydrochloride is an antihistamine used to treat allergy symptoms.  

Jolynn Tumolo

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