Why it was recalled
cGMP deviations
Product description
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
Lot numbers, UPCs & expiration codes
Lot, expiry: UDE-01, EXP: OCT 26
Where it was sold
DE
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-0384-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 15, 2025
- FDA report date
- Apr 30, 2025
- Quantity
- 10,752 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmadel, LLC
Original FDA data
Every field from FDA enforcement report D-0384-2025, exactly as published.
Show all FDA fields
- City
- Historic New Castle
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 96639
- Address
- 650 Centerpoint Blvd
- Code information
- Lot, expiry: UDE-01, EXP: OCT 26
- Postal code
- 19720-8108
- Report date
- Apr 30, 2025
- Product type
- Drugs
- Recall number
- D-0384-2025
- Classification
- Class II
- Recalling firm
- Pharmadel, LLC
- Product quantity
- 10,752 bottles
- Termination date
- Jan 8, 2026
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
- Distribution pattern
- DE
- Recall initiation date
- Apr 15, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 21, 2025