FDAFDA · Food and drugs·Recall number D-0266-2025
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0
Published March 19, 2025 · Recall initiated: March 4, 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: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Chattem Inc
- Distributor
- Nationwide in the USA.
- Lot
- Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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