Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Optim V Recalled by KENIL HEALTHCARE PRIVATE LIMITED Due to CGMP Deviations

Date: April 24, 2025
Company: KENIL HEALTHCARE PRIVATE LIMITED
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact KENIL HEALTHCARE PRIVATE LIMITED directly.

Affected Products

Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.

Quantity: 6,372 Tubes

Why Was This Recalled?

CGMP Deviations

Where Was This Sold?

This product was distributed to 2 states: DE, NC

Affected (2 states)Not affected

About KENIL HEALTHCARE PRIVATE LIMITED

KENIL HEALTHCARE PRIVATE LIMITED has 20 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report