Chattem Inc: Drug Recall

Recall #D-0266-2025 · 03/04/2025

Class II: Risk

Recall Details

Recall Number: D-0266-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Chattem Inc
Status: Ongoing
Date Initiated: 03/04/2025
Location: Chattanooga, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 180,696 cartons

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide in the USA.

Other Recalls by Chattem Inc

Class II: Risk 03/26/2025

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

View all recalls by Chattem Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.