The Recall Desk
ModerateFDA (Drugs)·D-0427-2025·Announced 2025-05-28

Optim V anti-itch cream recalled for manufacturing deviations

Optim V anti-itch cream is recalled for manufacturing defects. The FDA Class II recall affects tubes distributed in Delaware and North Carolina.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II voluntary recall initiated by the manufacturer for manufacturing process deviations. No illnesses or injuries are reported in the source, and the recall is precautionary in nature.

Plain-English summary

Optim V anti-itch cream, a topical medication containing benzocaine 20% and resorcinol 3%, is being recalled. The product comes in 1 oz (28g) tubes and is distributed by Pharmadel LLC of New Castle, Delaware.

The recall was initiated by KENIL HEALTHCARE PRIVATE LIMITED, the manufacturer, due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process.

The affected product was distributed in Delaware and North Carolina. The recalled lot is SP24A with an expiration date of September 30, 2026. A total of 6,372 tubes are affected.

Consumers should stop using this product and return it to the place of purchase or contact the manufacturer for instructions.

The recalled product

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.
Manufacturer
KENIL HEALTHCARE PRIVATE LIMITED
Hazard
  • cgmp-deviation

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 (2)

  • Lot SP24A
  • Exp: 09/30/2026

Distribution

Distributed in 2 states:

  • DE
  • NC