Unisom recalled over manufacturing violations

Recall date

March 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Chattem Inc recalls Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry fla…

Recall number

D-0266-2025

FDA classification

Class II

Brand / firm

Chattem Inc

Sold / distributed

Nationwide in the USA.

Why it was recalled

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0