FDA Drugs recall ·
Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External… recall
- Recall number
- D-0427-2025
- Date
- (initiated April 24, 2025)
- Company / brand
- Kenil Healthcare Private Limited
Plot 319, Ta. Kadi, District Mehsana, N/A, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 6,372 Tubes
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
CGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot SP24A, Exp: 09/30/2026
Distribution
DE and NC
States: Delaware North Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0427-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.