Sleep Tablets Recalled

Citing deviations from Current Good Manufacturing Practice regulations, Ultra Seal Corporation is recalling over-the-counter melatonin sleep products distributed by multiple outlets throughout the United States. The recalls were included in the February 9, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following products:

• REMfresh Lite (melatonin 0.5 mg) tablets, 36-count blister packs from lots 19E058A and 19E058B (Exp. 5/22), distributed by Physician’s Seal, Boca Raton, FL;
• MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles from lots 18L124, 18L125, and 18L126 (Exp. 2/22), 19C037, 19C038, 19C039, and 19C040 (Exp. 3/22), 19D029 and 19D030 (Exp. 4/22), 19D031 (Exp. 6/22), and 19G047 (Exp. 7/22), distributed by Mylan Consumer Healthcare Inc, Morgantown, WV; and
• MidNite Natural sleep aid, chewable, cherry-flavored tablets (melatonin 1.5 mg), 30-count bottles, from lots 19C038C (Exp. 3/22), 19G047C (Exp. 7/22), and 18L124C (Exp. 2/22), distributed by BGP Pharma ULC, Ontario, Canada.

Ultra Seal Corporation voluntarily initiated the recall January 24, 2022. The FDA designated the recall Class II on January 31, 2022. 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.

Melatonin is a dietary supplement used for the short-term treatment of insomnia.