Chattem recalls Unisom and SleepMinis mini-capsules due to detected nitrosamine impurities that exceed FDA safety limits. Consumers should stop using affected batches immediately.
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Chattem is recalling Unisom and SleepMinis mini-capsules because they contain nitrosamine impurities above FDA safety limits. This could pose a health risk if taken regularly.
The recalled mini-capsules contain n-dph, a nitrosamine impurity that exceeds the FDA's recommended safety limits. This impurity can potentially cause health issues if consumed over time, especially with regular use.
People who own or use Unisom or SleepMinis mini-capsules with the specific lot numbers and expiration dates listed in the recall notice are affected. Those taking these products regularly are at the highest risk.
Check for the product name 'Unisom' or 'SleepMinis' with 25 mg, 60 mini-capsules. Look for lot numbers 22L603 (expiring Oct 2025) or 378999 (expiring Feb 2027).
Immediately stop using the recalled Unisom or SleepMinis mini-capsules with the specified lot numbers and expiration dates.
The recall involves n-dph, a nitrosamine impurity that exceeds FDA safety limits.
Check for the product name 'Unisom' or 'SleepMinis' with 25 mg, 60 mini-capsules and lot numbers 22L603 (expiring Oct 2025) or 378999 (expiring Feb 2027).
The recall does not specify a return process, but you should stop using the product immediately.
We’ve drafted a message you can send Chattem to request your refund or repair — edit it as you like.
Subject: Recall D-0362-2025 — Chattem Chattem Hello, I own a Chattem that is covered by recall D-0362-2025 from Chattem. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
