Home / Recalls / Chattem Inc / D-0362-2025

D-0362-2025 Class II Ongoing

Recalled by Chattem Inc — Chattanooga, TN

FDA drug recall D-0362-2025 was initiated by Chattem Inc on Mar 26, 2025 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 129,240 bottles.

Recall details

Product Type: Drugs
Report Date: Apr 23, 2025
Initiation Date: Mar 26, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 129,240 bottles

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

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

Distribution pattern

Nationwide.

Code information

LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0362-2025
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.