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RECALL RECORD — CLASS IIRecall closedD-0422-2025/FDA enforcement
Kenil Healthcare Private Limited·Cosmetics·Apr 24, 2025

Cura Hongos, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 FL OZ (22.5 ML) Bottle, Dist…

What you need to know

Class II

  • What happened

    CGMP Deviations

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. Current good manufacturing practice failures can affect product identity, strength, quality or purity.

  • Action required

    Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement.

Recall closed · classified by the FDADE, NCMore cosmetics

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Match before you discard

Product identification

Source: FDA COSMETICS

Brand nameKenil Healthcare Private Limited
Recalling firmKenil Healthcare Private LimitedTa. Kadi, District Mehsana, India
UPC / barcodes
8 10096 77170 4
Lot / date codes
  • Lot SP31A, Exp Date: 09/30/2026
Distribution area
DENC

DE and NC

United States

Quantity affected10, 128 Bottles
Recall initiationFDA report date: May 28, 2025
FDA recall numberD-0422-2025

Beyond the headline

The recall, in context

Kenil Healthcare Private Limited initiated this cosmetics recall on April 24, 2025. The FDA enforcement report states: CGMP Deviations. The FDA report lists distribution as: DE and NC.

The FDA enforcement report describes the reason as: CGMP Deviations

Cura Hongos, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 FL OZ (22.5 ML) Bottle, Dist… was made or distributed by Kenil Healthcare Private Limited in Ta. Kadi, District Mehsana, India. This page reflects FDA report D-0422-2025, dated May 28, 2025.

Why this is a Class II recall

Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, current good manufacturing practice failures can affect product identity, strength, quality or purity.

FDA definition

The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.

What to do now

  1. 1

    Stop using it

    Set the product aside and do not apply it.

  2. 2

    Check the codes

    Compare the UPC and lot code against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Product safety recall

Symptoms to watch for

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Higher-risk groups

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What to do now

  1. 1Stop using or eating the product and keep it away from children and pets.
  2. 2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
  3. 3Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Read the official source record for the specific hazard and instructions.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Cura Hongos, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 FL OZ (22.5 ML) Bottle, Dist… recall?

Kenil Healthcare Private Limited recalled Cura Hongos, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 FL OZ (22.5 ML) Bottle, Dist… in an FDA Class II enforcement action reported as D-0422-2025. CGMP Deviations

What should I do if I bought this product?

Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Is the Kenil Healthcare Private Limited recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record D-0422-2025. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.