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: Nitrosamine Drug Substance Related Issue impurity...
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, 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
Quantity: 180,696 cartons
Why Was This Recalled?
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
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