Why it was recalled
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Product description
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
Lot numbers, UPCs & expiration codes
Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0266-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 4, 2025
- FDA report date
- Mar 19, 2025
- Quantity
- 180,696 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Chattem Inc
Original FDA data
Every field from FDA enforcement report D-0266-2025, exactly as published.
Show all FDA fields
- City
- Chattanooga
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96391
- Address
- 1715 W 38th St
- Code information
- Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
- Postal code
- 37409-1248
- Report date
- Mar 19, 2025
- Product type
- Drugs
- Recall number
- D-0266-2025
- Classification
- Class II
- Recalling firm
- Chattem Inc
- Product quantity
- 180,696 cartons
- Reason for recall
- CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 4, 2025
- Center classification date
- Mar 10, 2025