March 2025 FDA Recall Drug by Chattem Inc (D-0362-2025 - CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit)

This Class II drug recall was voluntarily initiated by Chattem Inc on March 26, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations; detection of nitrosamine drug substance-related impurities (ndsri), n-nitroso-desmethyl-diphenhydramine (n-dph), above the fda recommended intake limit. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0362-2025

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
Initiated
03-26-2025
Reported
04-23-2025
Quantity
129,240 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96552
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Chattem Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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