FDA Recall D-0362-2025

Chattem Inc · Chattanooga, TN

Class II Ongoing 414 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

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

Recall record

Recall number: D-0362-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Nationwide.
Recall initiated: 2025-03-26
Classified by FDA Center: 2025-04-11
FDA published: 2025-04-23
Recalling firm: Chattem Inc
Firm location: Chattanooga, TN

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls