Class IIOngoing

Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, D… recall

FDA recall D-0362-2025 · initiated Mar 26, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

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

Details

Product: 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
Recalling company: Chattem
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide.
Initiated: Mar 26, 2025
FDA report date: Apr 23, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0362-2025 ↗

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