Optim V Anti-Itch Cream Recalled for Current Good Manufacturing Practice Deviations
Optim V Anti-Itch Cream (Benzocaine 20% & Resorcinol 3%) is being recalled because the manufacturer did not follow current good manufacturing practice (CGMP) standards. The voluntary recall affects 6,372 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: This is a voluntary FDA Class II recall based on CGMP deviations rather than a specific identified contamination, defect, or ingredient issue. The source text does not report any illnesses, injuries, or confirmed adverse health consequences; the recall is precautionary in nature.
Plain-English summary
Optim V Anti-Itch Cream, a topical external analgesic containing Benzocaine 20% and Resorcinol 3%, is being voluntarily recalled by the manufacturer KENIL HEALTHCARE PRIVATE LIMITED due to CGMP deviations. The product is a 1 oz (28g) tube distributed by Pharmadel LLC of New Castle, Delaware. NDC number 55758-300-01 and UPC 859424004206 are affected.
The recall involves 6,372 tubes of Lot SP24A with an expiration date of 09/30/2026. Distribution was limited to Delaware and North Carolina.
Consumers who have purchased this product should stop using it. Because the reason for recall relates to manufacturing practice violations and not a specific safety hazard, consult a healthcare provider if you have questions about whether you have been affected or about alternative treatments.
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
- Affected units
- 6,372
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
Part of a larger recall action
This product is one of 20 recalled by KENIL HEALTHCARE PRIVATE LIMITED under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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