Chattem recalls Unisom and SleepMelts 25mg diphenhydramine tablets due to nitrosamine impurity exceeding FDA limits. Affected lots expire May 2025 through April 2026. Consumers should check product labels for specific lot numbers.
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Chattem is recalling Unisom and SleepMelts sleep aids containing diphenhydramine because they have a harmful nitrosamine impurity above FDA safety limits. This could pose a health risk with long-term use, but the recall does not require immediate stopping of use.
The tablets contain a nitrosamine impurity that exceeds the FDA's daily safe intake limit. Nitrosamines are known carcinogens that can increase cancer risk with prolonged exposure. This issue arose from manufacturing deviations that affected specific batches.
People who own or use Unisom or SleepMelts 25mg diphenhydramine tablets with the specific lot numbers listed in the recall. Those taking these sleep aids regularly are most at risk due to potential long-term health effects.
Check the product label for the cherry flavor, 25mg diphenhydramine, and 4 x 8 blister packs per carton. Look for lot numbers 252807 (expires May 31, 2025), 252808 (expires June 30, 2025), 372560 (expires November 30, 2025), 489576 or 493447 (expires April 30, 2026).
Look for the cherry flavor, 25mg diphenhydramine, and 4 x 8 blister packs per carton on the label.
Confirm the product has one of the specific lot numbers listed: 252807, 252808, 372560, 489576, or 493447.
The tablets contain a nitrosamine impurity that exceeds the FDA's daily safe intake limit, which could increase cancer risk with long-term use.
Check the label for cherry flavor, 25mg diphenhydramine, and 4 x 8 blister packs per carton. The affected lot numbers are 252807 (expires May 31, 2025), 252808 (expires June 30, 2025), 372560 (expires November 30, 2025), 489576 or 493447 (expires April 30, 2026).
No, the recall does not require immediate stopping of use. However, you should check if your product is affected and follow the steps to identify and handle the specific lots.
We’ve drafted a message you can send Chattem to request your refund or repair — edit it as you like.
Subject: Recall D-0266-2025 — Chattem Chattem Hello, I own a Chattem that is covered by recall D-0266-2025 from Chattem. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
