FDAFDA · Food and drugs·Recall number D-0362-2025
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
Published April 23, 2025 · Recall initiated: March 26, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Chattem Inc
- Distributor
- Nationwide.
- Lot
- LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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