Unisom SleepMelts Sleep-Aid Tablets Recalled for Nitrosamine Impurity
Chattem Inc. is recalling Unisom SleepMelts diphenhydramine HCl 25 mg tablets nationwide due to a nitrosamine impurity detected above FDA's acceptable daily intake limit. Affected lots expire between May 2025 and April 2026.
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 involving a nitrosamine impurity above the acceptable daily intake limit—a recognized health risk in pharmaceuticals. Per the severity rubric, a risk-of-harm product without reported injury receives a High rating.
Plain-English summary
Chattem Inc. is recalling Unisom SleepMelts, a 25 mg diphenhydramine HCl sleep-aid tablet product, due to a manufacturing quality issue. The recall affects approximately 180,696 cartons distributed nationwide in the United States.
Testing identified a nitrosamine impurity in the product at levels exceeding the FDA's acceptable daily intake limit. This Class II recall indicates a significant deviation from good manufacturing practices (CGMP deviations). Nitrosamines are recognized as substances of concern in pharmaceutical products due to potential health risks.
The affected lots are 252807, 252808, 372560, 489576, and 493447, with expiration dates ranging from May 31, 2025, to April 30, 2026. Consumers with these lots should stop using the product.
The recalled product
- Product
- 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
- Manufacturer
- Chattem Inc
- Hazard
- nitrosamine-impurity
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 (9)
- Lot# 252807
- Exp: 5/31/2025
- 252808
- Exp: 6/30/2025
- 372560
- Exp: 11/30/2025
- 489576
- 493447
- Exp: 4/30/2026.
Distribution
Distributed nationwide across the United States.
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