Unisom recalled over manufacturing violations

Recall date

March 26, 2025

Source

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

Official notice title

Chattem Inc recalls Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. B…

Recall number

D-0362-2025

FDA classification

Class II

Brand / firm

Chattem Inc

Sold / distributed

Nationwide.

Why it was recalled

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

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, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2