RECALL RECORD — CLASS IIRecall closedF-0159-2023/FDA enforcement
Abbott Laboratories·Food·Oct 13, 2022

Similac 360 Total Care Sensitive with Nipples 2 FL OZ Reclose Able Plastic Bottle Packaged as: …

What you need to know

Class II
  • What happened

    Compromised seal integrity which could lead to spoilage

  • 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

    Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice.

Recall closed · classified by the FDADCMore food

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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
  • Batch No. 35609N200 Case No. 380124R00 Product No. 68130 Best By 12/01/22
Distribution area
DC

Domestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming Foreign: Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia

United States, Canada, Mexico, Puerto Rico

Quantity affected14, 588, 544 bottles TOTAL
Recall initiationFDA report date: November 23, 2022
FDA recall numberF-0159-2023

Beyond the headline

The recall, in context

Abbott Laboratories initiated this food recall on October 13, 2022. The FDA enforcement report states: Compromised seal integrity which could lead to spoilage. The FDA report lists distribution as: Domestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming Foreign: Canada, Puerto Rico, Bermuda, Curacao, Trinidad, Tobago, Panama, Dominican Republic, and Colombia.

The FDA enforcement report describes the reason as: Compromised seal integrity which could lead to spoilage

Similac 360 Total Care Sensitive with Nipples 2 FL OZ Reclose Able Plastic Bottle Packaged as: … was made or distributed by Abbott Laboratories in Columbus, OH, United States. This page reflects FDA report F-0159-2023, dated November 23, 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

    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 360 Total Care Sensitive with Nipples 2 FL OZ Reclose Able Plastic Bottle Packaged as: … recall?

Abbott Laboratories recalled Similac 360 Total Care Sensitive with Nipples 2 FL OZ Reclose Able Plastic Bottle Packaged as: … in an FDA Class II enforcement action reported as F-0159-2023. Compromised seal integrity which could lead to spoilage

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?

Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice. 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-0159-2023 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-0159-2023. 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

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