RECALL RECORD — CLASS IIRecall closedD-0434-2017/FDA enforcement

Gel, 1.2%/5%, 45 g Tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed By…

What you need to know

Class II
  • What happened

    Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. Visible or laboratory-detected mold can signal a moisture, temperature or seal failure.

  • 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 nameClindamycin Phosphate and Benzoyl Peroxide
Recalling firmL. Perrigo CompanyAllegan, MI, United States
UPC / barcodes
3 45802 73684 0
Lot / date codes
  • 080806 (exp 12/16) 080844 ( exp 12/16) 080963 (exp 12/16) 080999 ( exp 12/16) 0841 09 ( exp 03/17 084197 ( exp 03/17) 091 090 ( exp 1 0/17) 092319 (exp 11/17) 092399 ( exp 12/17) 092440 ( exp 12/17)
Distribution area
Nationwide

Nationwide

United States

Quantity affected162, 534 tubes
Recall initiationFDA report date: January 25, 2017
FDA recall numberD-0434-2017

Beyond the headline

The recall, in context

L. Perrigo Company initiated this cosmetics recall on December 28, 2016. The FDA enforcement report states: Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap. The FDA report lists distribution as: Nationwide.

The FDA enforcement report describes the reason as: Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap

Gel, 1.2%/5%, 45 g Tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed By… was made or distributed by L. Perrigo Company in Allegan, MI, United States. This page reflects FDA report D-0434-2017, dated January 25, 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, visible or laboratory-detected mold can signal a moisture, temperature or seal failure.

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

Mold contamination

Symptoms to watch for

Eating a moldy product may cause nausea, vomiting, diarrhea or allergic reactions. Do not intentionally inspect, smell or taste a suspect product.

Higher-risk groups

People with mold allergies, asthma, a weakened immune system, pregnant people and young children should be especially cautious.

What to do now

  1. 1Stop using or eating the affected product and keep it away from children and pets.
  2. 2Match the product against the UPC and lot/date codes on this page, then dispose of it safely or return it to the retailer.
  3. 3If you have already been exposed and develop severe or worsening symptoms, seek medical advice promptly.

Visible mold can indicate a moisture, packaging or temperature failure.

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 Gel, 1.2%/5%, 45 g Tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed By… recall?

Clindamycin Phosphate and Benzoyl Peroxide recalled Gel, 1.2%/5%, 45 g Tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed By… in an FDA Class II enforcement action reported as D-0434-2017. Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap

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 affected product and keep it away from children and pets. Match the product against the UPC and lot/date codes on this page, then dispose of it safely or return it to the retailer. If you have already been exposed and develop severe or worsening symptoms, seek medical advice promptly.

Is the Clindamycin Phosphate and Benzoyl Peroxide 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-0434-2017. 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

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