Why it was recalled
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Product description
Benadryl, 25'S 2PK Box, UPC 815556020316
Lot numbers, UPCs & expiration codes
All lots within expiry distributed by Gold Star Distribution.
Where it was sold
US 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-0264-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 26, 2025
- FDA report date
- Jan 21, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GOLD STAR DISTRIBUTION INC
Original FDA data
Every field from FDA enforcement report D-0264-2026, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 98239
- Address
- 1000 Humboldt Ave N
- Code information
- All lots within expiry distributed by Gold Star Distribution.
- Postal code
- 55411-3964
- Report date
- Jan 21, 2026
- Product type
- Drugs
- Recall number
- D-0264-2026
- Classification
- Class II
- Recalling firm
- GOLD STAR DISTRIBUTION INC
- Reason for recall
- CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Benadryl, 25'S 2PK Box, UPC 815556020316
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Dec 26, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 14, 2026