# FDA recall D-0427-2025

> **KENIL HEALTHCARE PRIVATE LIMITED** · Class II · drug recall initiated 2025-04-24.

## Product

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.

## Reason for recall

CGMP Deviations

## Distribution

DE and NC

## Key facts

- **Recall number:** D-0427-2025
- **Recalling firm:** KENIL HEALTHCARE PRIVATE LIMITED
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2025-04-24
- **Report date:** 2025-05-28
- **Termination date:** 2026-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ta. Kadi, District Mehsana, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0427-2025

## Citation

> AI Analytics. FDA recall D-0427-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0427-2025. Source: US FDA. Licensed CC0.

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