Reported Mar 19, 2025 · Ongoing
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry…
Chattem Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Chattem Inc · 1715 W 38th St · Chattanooga, TN · 37409-1248
Is this the product you have?
- 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
- Lot codes and dates
- Lot# 252807
- Exp
5/31/2025252808
- Exp
6/30/2025372560
- Exp
11/30/2025489576493447
- Exp4/30/2026
- Amount recalled
- 180,696 cartons
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
This product could cause temporary or reversible health problems — stop using it.
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