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RECALL RECORD — CLASS IIIRecall closedD-162-2013/FDA enforcement
Ranbaxy INC.·Cosmetics·Dec 27, 2012

Lac-hydrin (Ammonium Lactate) Lotion, 12%, Packaged in 400 g Bottles, Rx Only, Ranbaxy, …

What you need to know

Class III

  • What happened

    Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.

  • 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 nameRanbaxy INC.
Recalling firmRanbaxy INC.Princeton, NJ, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot #: RB93911, Exp 07/14
Distribution area
Nationwide

Nationwide and Puerto Rico

United States, Puerto Rico

Quantity affected4, 016 bottles
Recall initiationFDA report date: February 20, 2013
FDA recall numberD-162-2013

Beyond the headline

The recall, in context

Ranbaxy INC. initiated this cosmetics recall on December 27, 2012. The FDA enforcement report states: Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product. The FDA report lists distribution as: Nationwide and Puerto Rico.

The FDA enforcement report describes the reason as: Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.

Lac-hydrin (Ammonium Lactate) Lotion, 12%, Packaged in 400 g Bottles, Rx Only, Ranbaxy, … was made or distributed by Ranbaxy INC. in Princeton, NJ, United States. This page reflects FDA report D-162-2013, dated February 20, 2013.

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 Lac-hydrin (Ammonium Lactate) Lotion, 12%, Packaged in 400 g Bottles, Rx Only, Ranbaxy, … recall?

Ranbaxy INC. recalled Lac-hydrin (Ammonium Lactate) Lotion, 12%, Packaged in 400 g Bottles, Rx Only, Ranbaxy, … in an FDA Class III enforcement action reported as D-162-2013. Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the 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 Ranbaxy 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-162-2013. 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.