Antihistamine Recalled

Plastikon Healthcare is recalling more than a half-million cups of diphenhydramine hydrochloride because the medication was manufactured under conditions that reflect inadequately controlled manufacturing processes, according to the September 14, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were labeled and distributed throughout the United States by Major Pharmaceuticals:

• diphenhydramine hydrochloride oral solution, 12.5 mg/5 mL, 5-mL cups, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6740-70), for institutional use only, Major Pharmaceuticals, from lots 20063A (Exp. 6/22), 20098A (Exp. 10/22), 21055B (Exp. 5/23), 21066A (Exp. 6/23), 21083B (Exp. 7/23), 21112B (Exp. 10/23), and 22009A (Exp. 2/24); and
• diphenhydramine hydrochloride oral solution, 25 mg/10 mL, 10-mL cups, packaged 10 cups per tray, 10 trays per carton (NDC 0904-6741-72), for institutional use only, Major Pharmaceuticals, from lots 20065A (Exp. 6/22), 20068A and 20070A (Exp. 7/22), 20097A and 20098A (Exp. 10/22), 21055A (Exp. 5/23), 21083A (Exp. 7/23), 21091A (Exp. 8/23), and 21112A (Exp. 10/23).

On June 7, 2022, Plastikon Healthcare voluntarily initiated the recall. On September 6, 2022, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Diphenhydramine hydrochloride is an over-the-counter antihistamine.