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RECALL RECORD — CLASS IIRecall closedF-0328-2024/FDA enforcement
Abbott Laboratories·Dietary Supplements·Oct 31, 2023

Similac Probiotic Tri-blend - 0.017oz (0.50g) Packaged in Foil Packets

What you need to know

Class II

  • What happened

    Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

  • 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 taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.

Recall closed · classified by the FDADistribution not listedMore supplements

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Product identification

Source: FDA FOOD

Brand nameAbbott Laboratories
Recalling firmAbbott LaboratoriesColumbus, OH, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot No. 45002IP Product No. 67397 Best By 09/01/24
Distribution area

Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

Mexico

Quantity affected226, 650 packets (4, 533 cartons)
Recall initiationFDA report date: November 15, 2023
FDA recall numberF-0328-2024

Beyond the headline

The recall, in context

Abbott Laboratories initiated this supplements recall on October 31, 2023. The FDA enforcement report states: Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive. The FDA report lists distribution as: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia.

The FDA enforcement report describes the reason as: Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

Similac Probiotic Tri-blend - 0.017oz (0.50g) Packaged in Foil Packets was made or distributed by Abbott Laboratories in Columbus, OH, United States. This page reflects FDA report F-0328-2024, dated November 15, 2023.

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

    Do not eat, drink or take the affected product.

  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 Similac Probiotic Tri-blend - 0.017oz (0.50g) Packaged in Foil Packets recall?

Abbott Laboratories recalled Similac Probiotic Tri-blend - 0.017oz (0.50g) Packaged in Foil Packets in an FDA Class II enforcement action reported as F-0328-2024. Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

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 taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. 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 Abbott Laboratories?

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 F-0328-2024 and keep the packaging, lot code and proof of purchase if you have them.

Is the Abbott Laboratories 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 F-0328-2024. 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.