Chattem Inc: Drug Recall

Recall #D-0362-2025 · 03/26/2025

Class II: Risk

Recall Details

Recall Number: D-0362-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Chattem Inc
Status: Ongoing
Date Initiated: 03/26/2025
Location: Chattanooga, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 129,240 bottles

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide.

Other Recalls by Chattem Inc

Class II: Risk 03/04/2025

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

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.