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RECALL RECORD — CLASS IIRecall closedD-0297-2022/FDA enforcement
Teligent Pharma, INC.·Cosmetics·Aug 23, 2021

Betamethasone Dipropionate Lotion Usp, 0.05% (Augmented), 30 ML Bottle, (29 g), Rx Only, …

What you need to know

Class II

  • What happened

    Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability…

  • 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 nameTeligent Pharma, INC.
Recalling firmTeligent Pharma, INC.Buena, NJ, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot # 16569, Exp 9/2022
Distribution area
Nationwide

Distributed Nationwide in the USA

United States

Quantity affected3, 792 bottles
Recall initiationFDA report date: January 5, 2022
FDA recall numberD-0297-2022

Beyond the headline

The recall, in context

Teligent Pharma, INC. initiated this cosmetics recall on August 23, 2021. The FDA enforcement report states: Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing. The FDA report lists distribution as: Distributed Nationwide in the USA.

The FDA enforcement report describes the reason as: Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing

Betamethasone Dipropionate Lotion Usp, 0.05% (Augmented), 30 ML Bottle, (29 g), Rx Only, … was made or distributed by Teligent Pharma, INC. in Buena, NJ, United States. This page reflects FDA report D-0297-2022, dated January 5, 2022.

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, 0.05% (Augmented), 30 ML Bottle, (29 g), Rx Only, … recall?

Teligent Pharma, INC. recalled Betamethasone Dipropionate Lotion Usp, 0.05% (Augmented), 30 ML Bottle, (29 g), Rx Only, … in an FDA Class II enforcement action reported as D-0297-2022. Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability…

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 Teligent Pharma, 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-0297-2022. 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 Teligent Pharma, INC.

View brand
Class II·

Teligent Pharma, INC.

Hydrocortisone Butyrate Lotion, 0.1%, Packaged in a) 2 FL OZ (59 ML) Bottles

CGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Nationwide (US) +1 countriesCosmetics
Class II·

Teligent Pharma, INC.

Clobetasol Propionate Lotion, 0.05%, Packaged in a) 2 FL

CGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Nationwide (US) +1 countriesCosmetics

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