Why it was recalled
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Product description
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
Lot numbers, UPCs & expiration codes
LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027
Where it was sold
Nationwide.
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-0362-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 26, 2025
- FDA report date
- Apr 23, 2025
- Quantity
- 129,240 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Chattem Inc
Original FDA data
Every field from FDA enforcement report D-0362-2025, exactly as published.
Show all FDA fields
- City
- Chattanooga
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96552
- Address
- 1715 W 38th St
- Code information
- LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027
- Postal code
- 37409-1248
- Report date
- Apr 23, 2025
- Product type
- Drugs
- Recall number
- D-0362-2025
- Classification
- Class II
- Recalling firm
- Chattem Inc
- Product quantity
- 129,240 bottles
- Reason for recall
- CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
- Distribution pattern
- Nationwide.
- Recall initiation date
- Mar 26, 2025
- Center classification date
- Apr 11, 2025