During a week when sleep is already disrupted, one long-trusted brand name is being flagged for a potential health risk.
Nearly 200,000 Containers of a Popular Sleep Aid Recalled Nationwide
Published on Mar. 11, 2025
Springing forward is no joke when it comes to sleep patterns. A few years ago, a survey by the American Academy of Sleep Medicine produced the finding that that 55% of Americans typically report feeling tired for days after the hour lost when Daylight Saving Time takes effect.
Before there were bedtime gummies, melatonin, and magnesium as popular sleep supplements, there were over-the-counter sleep aids like Unisom. This week a Unisom quick-dissolve product, which was likely developed at least in part in response to the prominence of chewable products, is under a sizable recall for what the government is flagging as possible cancer-causing issues.
On March 4, a nationwide recall was executed on 180,696 total packages of Unisom SleepMelts nighttime sleep-aids. Six days later, this past Monday, the U.S. Food and Drug Administration (FDA) worked fast to designate this as a Class II recall, indicating the products “may cause temporary or medically reversible adverse health effects.”
Recalled Unisom details are, according to the FDA:
- Unisom SleepMelts Nighttime Sleep Aid, 25 milligrams (mg)
- 32 tablets per carton (4 x 8 blister packs)
- Cherry flavor
- UPC 04116700140
- Lot Code 252807, Best By Date: 5/31/2025
- Lot Code 252808, Best By Date: 6/30/2025
- Lot Code 372560, Best By Date: 11/30/2025
- Lot Code 489576, Best By Date: 4/30/2026
- Lot Code 493447, Best By Date: 4/30/2026
- Manufactured by Adare Pharmaceuticals, Inc., Distributed by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409
The FDA says the product is being recalled for “CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.” This likely means the product does not meet the FDA’s standards for Current Good Manufacturing Practice, specifically when it comes to nitrosamine impurity levels.
Nitrosamine has gained warnings from the FDA for its “the mutagenic and carcinogenic potential.” The “mutagenic” reference could point to the drug’s ability to cause DNA mutations, while “carcinogenic” suggests possible cancer-producing properties.
Last Friday, drugstore chain CVS also posted information on their website concerning the recall, suggesting customers who purchased any of the recalled product “should immediately discontinue use of it. A full refund can be obtained by returning product purchased at CVS Pharmacy to a nearby store.” A brief online search shows Unisom products are also sold at Target, Walgreens, Walmart, Amazon, and other major retailers.
The Cleveland Clinic says Unisom’s active ingredient, doxylamine, is indicated to treat “occasional insomnia.” The Unisom website suggests it is the number one doctor-recommend sleep aid brand that’s available over the counter (without a prescription).
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