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RECALL RECORD — CLASS IIIRecall closedD-0859-2017/FDA enforcement
Vintage Pharmaceuticals LLC, Dba Qualitest Pharmaceuticals·Cosmetics·May 8, 2017

Hydrocortisone Lotion, Usp, 2.5%, 2 FL OZ (59 ML) Bottle, Rx Only, Manufactured for: Qualitest…

What you need to know

Class III

  • What happened

    Superpotent Drug: above specification for the assay.

  • 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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Match before you discard

Product identification

Source: FDA COSMETICS

Brand nameVintage Pharmaceuticals LLC, Dba Qualitest Pharmaceuticals
Recalling firmVintage Pharmaceuticals LLC, Dba Qualitest PharmaceuticalsHuntsville, AL, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot #: 0000004961, Exp. 05/17
  • 0000005197, 0000005198, 0000005199, Exp. 07/17
  • 0000005201, 0000005202, 0000005203, 0000005204, Exp. 09/17
  • 0000005200, 0000007998, 0000007999, 0000007022, Exp. 12/17
  • 0000009176, Exp. 04/18
  • 0000012281, 0000012282, Exp. 12/18
Distribution area
Nationwide

Nationwide in the USA and Puerto Rico.

United States, Puerto Rico

Quantity affected109, 620 bottles
Recall initiationFDA report date: May 31, 2017
FDA recall numberD-0859-2017

Beyond the headline

The recall, in context

Vintage Pharmaceuticals LLC, Dba Qualitest Pharmaceuticals initiated this cosmetics recall on May 8, 2017. The FDA enforcement report states: Superpotent Drug: above specification for the assay. The FDA report lists distribution as: Nationwide in the USA and Puerto Rico.

The FDA enforcement report describes the reason as: Superpotent Drug: above specification for the assay.

Hydrocortisone Lotion, Usp, 2.5%, 2 FL OZ (59 ML) Bottle, Rx Only, Manufactured for: Qualitest… was made or distributed by Vintage Pharmaceuticals LLC, Dba Qualitest Pharmaceuticals in Huntsville, AL, United States. This page reflects FDA report D-0859-2017, dated May 31, 2017.

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 Hydrocortisone Lotion, Usp, 2.5%, 2 FL OZ (59 ML) Bottle, Rx Only, Manufactured for: Qualitest… recall?

Vintage Pharmaceuticals LLC, Dba Qualitest Pharmaceuticals recalled Hydrocortisone Lotion, Usp, 2.5%, 2 FL OZ (59 ML) Bottle, Rx Only, Manufactured for: Qualitest… in an FDA Class III enforcement action reported as D-0859-2017. Superpotent Drug: above specification for the assay.

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 Vintage Pharmaceuticals LLC, Dba Qualitest Pharmaceuticals 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-0859-2017. 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.