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RECALL RECORD — CLASS IIRecall closedD-0802-2021/FDA enforcement
Akorn, INC.·Cosmetics·Aug 13, 2021

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

What you need to know

Class II

  • What happened

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

  • Health risk

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

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 #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022
Distribution area
Nationwide

USA Nationwide

United States

Quantity affected264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
Recall initiationFDA report date: September 22, 2021
FDA recall numberD-0802-2021

Beyond the headline

The recall, in context

Akorn, INC. initiated this cosmetics recall on August 13, 2021. The FDA enforcement report states: Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product. The FDA report lists distribution as: USA Nationwide.

The FDA enforcement report describes the reason as: Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

Betamethasone Dipropionate Lotion Usp (Augmented), 0.05%, Packaged in a) 30 ML Bottle ( was made or distributed by Akorn, INC. in Lake Forest, IL, United States. This page reflects FDA report D-0802-2021, dated September 22, 2021.

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, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

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

Akorn, INC. recalled Betamethasone Dipropionate Lotion Usp (Augmented), 0.05%, Packaged in a) 30 ML Bottle ( in an FDA Class II enforcement action reported as D-0802-2021. Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

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-0802-2021. 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 III·

Akorn, INC.

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

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

Nationwide (US) +1 countriesCosmetics
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.