OTC Sleep Aid Recalled

LNK International Inc is recalling 257,064 cartons of Nighttime Sleep-Aid (doxylamine succinate HCl) tablets. According to the September 7, 2022, US Food and Drug Administration (FDA) Enforcement Report, the product carton “incorrectly identifies [the] product as doxylamine succinate HCl, however the product is doxylamine succinate.”

The recall affects Nighttime Sleep-Aid, 25-mg tablets, 48-count blisters per carton (UPC 0 50428 34873 4), from lots P121512 (Exp. 8/23), P122015 (Exp. 9/23), P122712 (Exp. 11/23), P123090 (Exp. 12/23), P123170 (Exp. 12/23), P124325 (Exp. 3/24), P124664 (Exp. 3/24), P125165 (Exp. 5/24), P125576 (Exp. 6/24), P125577 (Exp. 6/24), P127089 (Exp. 10/24), P127090 (Exp. 10/24), P127386 (Exp. 11/24), P128572 (Exp. 1/25), P128383 (Exp. 1/25), and P129536 (Exp. 4/25).

The recalled product was distributed by CVS Pharmacy Inc, Woonsocket, RI, to a single retailer that may have further distributed the product to other sites throughout the United States.

LNK International voluntarily initiated the recall August 4, 2022. On August 30, 2022, the FDA designated the recall Class III. Per the recall classification, use of the affected product is not likely to cause harm.

Nighttime Sleep-Aid tablets are used to reduce difficulty in falling asleep.