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

🇺🇸 United States

1. October 31, 2023 - Recall initiated
2. November 15, 2023 - Reported by source
3. September 3, 2024 - Recall terminated

Official source record

Agency

FDA

Dataset

FDA Food Enforcement (Recalls)

Recall number

F-0328-2024

Event ID

93348

Status

Terminated

Classification

Class II

Company

Abbott Laboratories

Product description

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

Quantity

226,650 packets (4,533 cartons)

Reason

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

Recall initiation date

October 31, 2023

Report date

November 15, 2023

Classification date

Not published in this source record

Termination date

September 3, 2024

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

UPC, lot, and code information

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

Voluntary or mandated

Voluntary: Firm initiated

Initial notification method

E-Mail

Source last updated

Not tracked separately from the Public Health Trace retrieval date below

Public Health Trace retrieval date

July 18, 2026 ET

Responsible company: Abbott Laboratories

Other recalls from Abbott Laboratories

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.

New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace: July 18, 2026 ET

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

Official guidance and record verification

Public Health Trace does not provide medical advice. The information below explains how to interpret this record and links to relevant official government sources. Review the linked official source for the current, authoritative information.

How to interpret this historical record

This record is preserved as published by FDA, as of September 3, 2024.

Status as reported: Terminated.

This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.

View the official FDA source

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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