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RECALL RECORD — CLASS IIRecall closedD-0570-2017/FDA enforcement
Synergy Rx·Cosmetics·Feb 10, 2017

Reverse Dml Lotion (Ketoconazole 2%, Metronidazole 2%, Sulfacetamide Sodium 10%), Rx Only, …

What you need to know

Class II

  • What happened

    Lack of Assurance of Sterility: There are also 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 FDANationwide (US)More cosmetics

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Product identification

Source: FDA COSMETICS

Brand nameSynergy Rx
Recalling firmSynergy RxSan Diego, CA, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • All Lots
Distribution area
Nationwide

Nationwide within the United States

United States

Quantity affectedNot provided by the FDA.
Recall initiationFDA report date: March 22, 2017
FDA recall numberD-0570-2017

Beyond the headline

The recall, in context

Synergy Rx initiated this cosmetics recall on February 10, 2017. The FDA enforcement report states: Lack of Assurance of Sterility: There are also CGMP Deviations. The FDA report lists distribution as: Nationwide within the United States.

The FDA enforcement report describes the reason as: Lack of Assurance of Sterility: There are also CGMP Deviations.

Reverse Dml Lotion (Ketoconazole 2%, Metronidazole 2%, Sulfacetamide Sodium 10%), Rx Only, … was made or distributed by Synergy Rx in San Diego, CA, United States. This page reflects FDA report D-0570-2017, dated March 22, 2017.

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 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

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 Reverse Dml Lotion (Ketoconazole 2%, Metronidazole 2%, Sulfacetamide Sodium 10%), Rx Only, … recall?

Synergy Rx recalled Reverse Dml Lotion (Ketoconazole 2%, Metronidazole 2%, Sulfacetamide Sodium 10%), Rx Only, … in an FDA Class II enforcement action reported as D-0570-2017. Lack of Assurance of Sterility: There are also CGMP Deviations.

What are the symptoms of Product safety recall exposure?

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.

Who is most at risk from Product safety recall?

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

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.

How do I get a refund from Synergy Rx?

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-0570-2017 and keep the packaging, lot code and proof of purchase if you have them.

Is the Synergy Rx 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-0570-2017. 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

Brand history

More recalls by Synergy Rx

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