Unisom SleepMinis diphenhydramine recalled for nitrosamine impurity
Chattem Inc is recalling Unisom SleepMinis 25 mg capsules nationwide due to detection of N-nitroso-desmethyl-diphenhydramine impurity above the FDA Recommended Intake Limit. Approximately 129,240 bottles from two lots are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for nitrosamine-related impurity exceeding the FDA Recommended Intake Limit. No illnesses or injuries are reported, but nitrosamine impurities are known genotoxic compounds of concern, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Chattem Inc is recalling Unisom SleepMinis diphenhydramine HCl 25 mg mini-capsules distributed nationwide in 60-capsule bottles. The recall affects approximately 129,240 bottles from LOT 22L603 (expiration October 2025) and LOT 378999 (expiration February 2027).
The recall was initiated due to detection of N-nitroso-desmethyl-diphenhydramine (NDSRI), a nitrosamine-related impurity, in the drug substance at levels above the FDA Recommended Intake Limit. These impurities resulted from CGMP (Current Good Manufacturing Practice) deviations identified during the manufacturing process.
Consumers who have purchased affected bottles should consult with their healthcare provider or pharmacist for guidance regarding their use of the product.
The recalled product
- Product
- 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
- Manufacturer
- Chattem Inc
- Category
- Drug — OTC Sleep Aid
- Hazard
- nitrosamine-impurity
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- LOT 22L603
- EXP: Oct 2025
- LOT 378999
- EXP: Feb 2027
Distribution
Distributed nationwide across the United States.
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