Chattem Inc is recalling approximately 180,696 cartons of Unisom SleepMelts (diphenhydramine HCl), 25 mg cherry-flavored nighttime sleep-aid tablets. The recall was initiated because testing detected a nitrosamine impurity (NDSRI) that exceeds the daily acceptable intake limit set by the FDA. The affected products are packaged in cherry-flavored blister packs with 32 tablets per carton.
The product contains a nitrosamine impurity above acceptable safety limits. While nitrosamines are common in water and food, long-term exposure to levels above the daily intake limit may increase the risk of cancer. No injuries or adverse events have been reported to date.
You have 2 options:
Manufactured by Adare Pharmaceuticals, Inc.; Distributed by Chattem, Inc.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.