Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Unisom Recalled by Chattem Inc Due to CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Chattem Inc directly.
Affected Products
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
Quantity: 129,240 bottles
Why Was This Recalled?
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Chattem Inc
Chattem Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report