Chattem Inc 2025-03-19 Health serious FDA
Health · FDA · Recall #FDA-D-0266-2025
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8… Recall
Issued March 19, 2025 · Chattem Inc
In March 2025, Chattem Inc recalled the Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
What you should do
- 1 Stop using Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8… 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
- March 19, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA.
- Recall number
- FDA-D-0266-2025
- 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.