Unisom SleepMinis diphenhydramine capsules recalled for nitrosamine impurity
Chattem Inc. is recalling Unisom SleepMinis 25 mg diphenhydramine capsules due to detection of nitrosamine impurity above FDA limits. Affected lots are 22L603 (exp. Oct 2025) and 378999 (exp. Feb 2027).
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with CGMP deviations and detection of a nitrosamine impurity. The source text does not report any illnesses or injuries, and the hazard is the presence of an impurity above acceptable limits. Per the rubric, Class II recalls without reported hospitalization or serious injury are typically Moderate (score 2).
Plain-English summary
Chattem Inc. is recalling 129,240 bottles of Unisom SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg distributed nationwide. The recall was initiated due to the detection of N-nitroso-desmethyl-diphenhydramine (n-dph), a nitrosamine drug substance-related impurity (NDSRI), at levels above the FDA Recommended Intake Limit.
The affected product lots are LOT 22L603 with an expiration date of October 2025 and LOT 378999 with an expiration date of February 2027. The product is identified by UPC 0 41167 00670 2.
Consumers who have purchased affected bottles should stop use and consult with a healthcare provider or pharmacist. Questions may be directed to Chattem Inc. at P.O. Box 2219, Chattanooga, TN 37409-0219.
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
- Affected units
- 129,240
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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