HIV Tablets Recalled

GlaxoSmithKline is recalling a single lot of Tivicay (dolutegravir) tablets manufactured for ViiV Healthcare Company because the label lists an incorrect expiration date. According to the June 1, 2022, US Food and Drug Administration (FDA) Enforcement Report, the product label incorrectly states a January 2027 expiration date instead of the correct expiration date of September 2026.

The recall affects Tivicay tablets, 50 mg, 30-count bottles (NDC 49702-228-13), from lot 2A9E, (Exp. 1/27). The medication was distributed throughout the United States.

GlaxoSmithKline voluntarily initiated the recall May13, 2022. On May 25, 2022, the FDA designated the recall Class III. Under the recall classification, use of the affected tablets is not likely to cause harm.

Tivicay is a prescription antiretroviral medication used with other medication to treat patients with human immunodeficiency virus-1 (HIV-1) infection.