OTC Antihistamine Recalled

BLI International Inc. is recalling a single lot of chlorpheniramine maleate tablets manufactured for Athlete's Needs Inc. According to the November 6, 2024, US Food and Drug Administration (FDA) Enforcement Report, the recalled tablets are superpotent.

The recall affects chlorpheniramine maleate 4-mg tablets, packaged in 24-count bottles (NDC 53185-277-24), from lot 24A27724 (Exp. 1/31/27). The packaged product was shipped to 2 private-label customers in Ohio and Missouri.

BLI International initiated the recall on October 21, 2024. On October 30, 2024, 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.

Chlorpheniramine maleate is an over-the-counter antihistamine for the temporary relief of sneezing, runny nose, itchy and watery eyes, and itching of the nose and throat due to upper respiratory allergies.