OTC Antihistamine Tablets Recalled

The Harvard Drug Group is recalling three lots of fexofenadine hydrochloride tablets distributed throughout the United States by Major Pharmaceuticals. According to the December 29, 2021, US Food and Drug Administration (FDA) Enforcement Report, samples from the lots failed to meet impurity/degradation specifications.

The recall affects 60-mg fexofenadine hydrochloride tablets packaged in 500-count bottles (NDC 0904-6979-40) from lots H00005 (Exp. 1/22), H00006 (Exp. 4/22), and H00007 (Exp. 7/22).

The Harvard Drug Group voluntarily initiated the recall August 3, 2021. On December 21, 2021, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Fexofenadine hydrochloride is an over-the-counter antihistamine medication used to relieve watery eyes, runny nose, and other allergy symptoms.