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Class II: temporary or reversible health riskTerminated

Abbott Laboratories Similac Probiotic Tri-Blend Recall

Similac Probiotic Tri-Blend - 0

Abbott Laboratories · Columbus, OH

Risk level
Class II
Reported by FDA
Nov 15, 2023
Recall ID
F-0328-2024
Check your lot numberHow we source this data

Summary

Abbott Laboratories recalled Similac Probiotic Tri-Blend starting Oct 31, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0328-2024 on Nov 15, 2023. Reason: Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive. Status: Terminated.

Why it was recalled

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

Product description

Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.

Lot numbers, UPCs & expiration codes

Lot No. 45002IP Product No. 67397 Best By 09/01/24

Where it was sold

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

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0328-2024
Classification
Class II
Status
Terminated
Recall initiated
Oct 31, 2023
FDA report date
Nov 15, 2023
Quantity
226,650 packets (4,533 cartons)
Recall type
Voluntary: Firm initiated
Recalling firm
Abbott Laboratories

Original FDA data

Every field from FDA enforcement report F-0328-2024, exactly as published.

Show all FDA fields
City
Columbus
State
OH
Status
Terminated
Country
United States
Event ID
93348
Address
2900 Easton Square Pl
Code information
Lot No. 45002IP Product No. 67397 Best By 09/01/24
Postal code
43219-6225
Report date
Nov 15, 2023
Product type
Food
Recall number
F-0328-2024
Classification
Class II
Recalling firm
Abbott Laboratories
Product quantity
226,650 packets (4,533 cartons)
Termination date
Sep 3, 2024
Reason for recall
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
Voluntary / mandated
Voluntary: Firm initiated
Product description
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Distribution pattern
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
Recall initiation date
Oct 31, 2023
Initial firm notification
E-Mail
Center classification date
Nov 7, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0328-2024, published Nov 15, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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