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RECALL RECORD — CLASS IIRecall closedD-1387-2012/FDA enforcement
Kutol Products Co INC·Cosmetics·May 21, 2012

Hands Down Medicated Lotion Soap, 1 Gallon Bottle, 4 Gallons Per Case, Distributed by Pcs…

What you need to know

Class II

  • What happened

    Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not…

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. An allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

  • 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 FDAILMore cosmetics

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Match before you discard

Product identification

Source: FDA COSMETICS

Brand nameKutol Products Co INC
Recalling firmKutol Products Co INCCincinnati, OH, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot #: 090204012, 090303026, 090508009, 090604024, 090725030, 090829002, 091005017, 091223002, 100115022, 100316005, 100115022, 100316005, 100329004, 100607017, 100730001, 100817014, 100921018, 101020009, 101208003, 101218007, 110405009, (L)11053105, (L)11062811, (L)11081805, and (L)11091206
Distribution area
IL

IL

United States

Quantity affected11, 688 gallon bottles (2, 922 cases)
Recall initiationFDA report date: June 27, 2012
FDA recall numberD-1387-2012

Beyond the headline

The recall, in context

Kutol Products Co INC initiated this cosmetics recall on May 21, 2012. The FDA enforcement report states: Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics. The FDA report lists distribution as: IL.

The FDA enforcement report describes the reason as: Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.

Hands Down Medicated Lotion Soap, 1 Gallon Bottle, 4 Gallons Per Case, Distributed by Pcs… was made or distributed by Kutol Products Co INC in Cincinnati, OH, United States. This page reflects FDA report D-1387-2012, dated June 27, 2012.

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, an allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

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 lot and date codes 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

Undeclared allergen

Symptoms to watch for

Hives, swelling, wheezing, coughing, vomiting, abdominal pain or a drop in blood pressure. Anaphylaxis is a medical emergency.

When symptoms may appear

Allergic reactions often begin within minutes to a few hours of eating the allergen.

Higher-risk groups

Anyone with a diagnosed food allergy, especially children, and people with a history of anaphylaxis or asthma.

What to do now

  1. 1Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy.
  2. 2If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services.
  3. 3Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

For a severe allergic reaction, do not wait for a callback or refund process before seeking emergency care.

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 Hands Down Medicated Lotion Soap, 1 Gallon Bottle, 4 Gallons Per Case, Distributed by Pcs… recall?

Kutol Products Co INC recalled Hands Down Medicated Lotion Soap, 1 Gallon Bottle, 4 Gallons Per Case, Distributed by Pcs… in an FDA Class II enforcement action reported as D-1387-2012. Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not…

What are the symptoms of Undeclared allergen exposure?

Hives, swelling, wheezing, coughing, vomiting, abdominal pain or a drop in blood pressure. Anaphylaxis is a medical emergency.

How quickly can Undeclared allergen symptoms appear?

Allergic reactions often begin within minutes to a few hours of eating the allergen.

Who is most at risk from Undeclared allergen?

Anyone with a diagnosed food allergy, especially children, and people with a history of anaphylaxis or asthma.

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. Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy. If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services. Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

How do I get a refund from Kutol Products Co INC?

Contact the recalling company or the retailer where you purchased the product, quote the FDA recall number and ask about a refund or replacement. Keep the packaging, lot code and proof of purchase where possible. The FDA does not issue consumer refunds. Reference FDA recall D-1387-2012 and keep the packaging, lot code and proof of purchase if you have them.

Is the Kutol Products Co INC 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-1387-2012. 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.