Chattem Inc 2025-04-23 Health serious FDA
Health · FDA · Recall #FDA-D-0362-2025
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles,… Recall
Issued April 23, 2025 · Chattem Inc
In April 2025, Chattem Inc recalled the Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
What you should do
- 1 Stop using Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Chattem Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Chattem Inc
- Category
- Health
- Recall date
- April 23, 2025
- Units affected
- Not reported
- Sold at
- Nationwide.
- Recall number
- FDA-D-0362-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Chattem Inc has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.