FDA Drugs recall ·
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg… recall
- Recall number
- D-0266-2025
- Date
- (initiated March 4, 2025)
- Company / brand
- Chattem Inc
1715 W 38th St, Chattanooga, TN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 180,696 cartons
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
Distribution
Nationwide in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0266-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.