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RECALL RECORD — CLASS IIIRecall closedD-0617-2018/FDA enforcement
Akorn, INC.·Cosmetics·Mar 9, 2018

Triamcinolone Acetonide Lotion, Usp 0.1%, 60 ML Bottle, Rx Only, Marketed by: Versapharm…

What you need to know

Class III

  • What happened

    Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

  • Health risk

    The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

  • 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 nameAkorn, INC.
Recalling firmAkorn, INC.Lake Forest, IL, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot# 2062900, Exp 05/18
Distribution area
Nationwide

Nationwide in the USA and Puerto Rico

United States, Puerto Rico

Quantity affected4, 128 bottles
Recall initiationFDA report date: March 28, 2018
FDA recall numberD-0617-2018

Beyond the headline

The recall, in context

Akorn, INC. initiated this cosmetics recall on March 9, 2018. The FDA enforcement report states: Failed Impurities/Degradation Specifications: High out of specification results for an impurity. The FDA report lists distribution as: Nationwide in the USA and Puerto Rico.

The FDA enforcement report describes the reason as: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Triamcinolone Acetonide Lotion, Usp 0.1%, 60 ML Bottle, Rx Only, Marketed by: Versapharm… was made or distributed by Akorn, INC. in Lake Forest, IL, United States. This page reflects FDA report D-0617-2018, dated March 28, 2018.

Why this is a Class III recall

Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

FDA definition

The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.

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 Triamcinolone Acetonide Lotion, Usp 0.1%, 60 ML Bottle, Rx Only, Marketed by: Versapharm… recall?

Akorn, INC. recalled Triamcinolone Acetonide Lotion, Usp 0.1%, 60 ML Bottle, Rx Only, Marketed by: Versapharm… in an FDA Class III enforcement action reported as D-0617-2018. Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

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 Akorn, 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-0617-2018. 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 Akorn, INC.

View brand
Class II·

Akorn, INC.

Betamethasone Dipropionate Lotion Usp (Augmented), 0.05%, Packaged in a) 30 ML Bottle (

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

Nationwide (US)Cosmetics
Class III·

Akorn, INC.

Triamcinolone Acetonide Lotion Usp, 0.025% Is Supplied in the Following Size: 60 ML (

Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

Nationwide (US)Cosmetics

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