Reported Apr 23, 2025 · Ongoing
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O.…
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, 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
- Lot codes and dates
- LOT 22L603
- EXP
Oct 2025LOT 378999
- EXPFeb 2027
- Amount recalled
- 129,240 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
This product could cause temporary or reversible health problems — stop using it.
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