The Recall Desk
HighFDA (Drugs)·D-0384-2025·Announced 2025-04-30

Homeopathic Urinary Tract Relief Drug Recalled for Manufacturing Deviations

Pharmadel is recalling Urodel, a homeopathic urinary tract infection relief tablet, due to manufacturing practice violations. The recall affects 10,752 bottles distributed in Delaware.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall without reported hospitalizations or illnesses, constituting a precautionary manufacturing compliance action. Per the rubric, absence of reported injury in a theoretical hazard context scores at most 3 (High).

Plain-English summary

Pharmadel, LLC is recalling Urodel, a homeopathic remedy for urinary tract infection symptom relief, distributed as 30-tablet chewable bottles with NDC 55758-406-30.

The recall was initiated due to Current Good Manufacturing Practices (cGMP) deviations at the manufacturing facility. These violations relate to manufacturing and quality control processes.

Approximately 10,752 bottles of Lot UDE-01 (expiration October 2026) were distributed in Delaware. The recall was voluntarily initiated by Pharmadel on April 15, 2025, and was terminated on January 8, 2026.

Consumers who possess this product should discontinue use and contact Pharmadel for instructions on product return or disposal.

The recalled product

Product
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
Manufacturer
Pharmadel, LLC
Category
Drug
Hazard
  • manufacturing-deviation
  • quality-control

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot
  • expiry: UDE-01
  • EXP: OCT 26

Distribution

Distributed in 1 state:

  • DE

Related recalls

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