CLASS II ONGOING Drug recall · Reported 19 Mar 2025 · FDA Enforcement Report
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg recalled
Chattem is recalling Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, blister, distributed nationwide in the US. The recall was initiated on 4 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0266-2025
- FDA event ID
- 96391
- Recalling firm
- Chattem, Chattanooga, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Mar 2025
- FDA classified
- 10 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Nitrosamine Impurity
- Drug class
- Allergy Medication
Timeline
| 4 Mar 2025 | Recall initiated by company | |
| 10 Mar 2025 | Classified by FDA | +6 days |
| 19 Mar 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Which lots are affected?
Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Chattem
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules recalled | Chattem | Nitrosamine Impurity | Nationwide |
Other Unisom recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules recalled | Chattem | Nitrosamine Impurity | Nationwide |