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RECALL RECORD — CLASS IIRecall closedD-0451-2016/FDA enforcement
Western Drug·Cosmetics·Oct 19, 2015

Serum Tears 20% Opth, Rx, Western Drug INC

What you need to know

Class II

  • What happened

    Lack of Assurance of Sterility

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. A process failure may have allowed harmful bacteria to survive in a product that is meant to be safe.

  • 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 nameWestern Drug
Recalling firmWestern DrugSpringerville, AZ, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • all lots
Distribution area
Nationwide

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

United States, Mexico

Quantity affected3 containers
Recall initiationFDA report date: December 9, 2015
FDA recall numberD-0451-2016

Beyond the headline

The recall, in context

Western Drug initiated this cosmetics recall on October 19, 2015. The FDA enforcement report states: Lack of Assurance of Sterility. The FDA report lists distribution as: Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.

The FDA enforcement report describes the reason as: Lack of Assurance of Sterility

Serum Tears 20% Opth, Rx, Western Drug INC was made or distributed by Western Drug in Springerville, AZ, United States. This page reflects FDA report D-0451-2016, dated December 9, 2015.

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 process failure may have allowed harmful bacteria to survive in a product that is meant to be safe.

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 Serum Tears 20% Opth, Rx, Western Drug INC recall?

Western Drug recalled Serum Tears 20% Opth, Rx, Western Drug INC in an FDA Class II enforcement action reported as D-0451-2016. Lack of Assurance of Sterility

What are the symptoms of Product safety recall exposure?

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.

Who is most at risk from Product safety recall?

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

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.

How do I get a refund from Western Drug?

Contact the recalling company or the retailer where you purchased the product, quote the FDA recall number and ask about a refund or replacement. Keep the packaging, lot code and proof of purchase where possible. The FDA does not issue consumer refunds. Reference FDA recall D-0451-2016 and keep the packaging, lot code and proof of purchase if you have them.

Is the Western Drug 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-0451-2016. 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.