Lower risk Food recall · FDA · Published October 31, 2023

Abbott Similac Probiotic Tri-Blend Recall: Unsafe for Preterm Infants

Abbott recalls Similac Probiotic Tri-Blend foil packets for preterm infants due to unsafe marketing and food additive concerns. Learn about affected products and safety steps.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #F-0328-2024Food Abbott ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmAbbott Laboratories2900 Easton Square Pl · Columbus, OH 43219-6225

✎ GovInfoNow plain-language explainer

Abbott is recalling Similac Probiotic Tri-Blend packets for preterm infants because they were marketed without proper approval as a drug or food additive. This could pose risks to infants' health. Read more at govinfonow.com/recall/10168-abbott-similac-probiotic-tri-blend-recall-unsafe-for-preterm-infants.

Source Summary by GovInfoNow · govinfonow.com/recall/10168-abbott-similac-probiotic-tri-blend-recall-unsafe-for-preterm-infants · Updated August 17, 2026 · FDA enforcement record: FDA #F-0328-2024

Cite this page

“Abbott Similac Probiotic Tri-Blend Recall: Unsafe for Preterm Infants.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/10168-abbott-similac-probiotic-tri-blend-recall-unsafe-for-preterm-infants. Based on FDA recall #F-0328-2024 (https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-0328-2024%22&limit=1).

The FDA announced on 2023-10-31 that Abbott Laboratories is recalling Similac Probiotic Tri-Blend due to its marketing as a new drug without approval and the presence of an unsafe food additive. This Class II recall affects approximately 226,650 packets distributed across multiple states.

How to tell if you have it

Brand: Abbott
Product: Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets
Lot No.: 45002IP
Product No.: 67397
Best By: 09/01/24

The hazard

According to the FDA, the product is marketed towards preterm infants without approval as a new drug or licensed biologic, and contains an unsafe food additive.

Context

GovInfoNow's records show Abbott Laboratories has 33 other recalls on record since 2012-05-14. Recent Abbott recalls include the Alinity ci-series System Control Module correction on 2025-11-13, the Alinity hq Analyzer Software Issue on 2025-09-18, and the CELL-DYN Ruby expired reagent issue on 2025-03-18. Other recent recalls of similar products include a2 Platinum Premium Infant Formula Recall (2026-05-01), Nara Organics Infant Formula Recall (2026-06-13), and Wellnov Liposomal Prenatal Multivitamin Drops Recall (2026-04-23).

How to tell if you have this one

Check for Similac Probiotic Tri-Blend packets in foil, with 50 per carton and 3 cartons per case. Lot No. 45002IP and Product No. 67397 are associated with this recall.

Brand
Abbott
Category
Food

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for Lot No. 45002IP and Product No. 67397 on the packaging to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed in 41 states.

FDA distribution: “Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

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

Recall timeline

FDA terminated this recall 10 months after the firm started it.

Oct 31, 2023Firm started the recall
Nov 7, 2023FDA classified it Class II
Nov 15, 2023Published in FDA’s Enforcement Report
Sep 3, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/10168-abbott-similac-probiotic-tri-blend-recall-unsafe-for-preterm-infants">Abbott Similac Probiotic Tri-Blend Recall: Unsafe for Preterm Infants (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #F-0328-2024 (October 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for F-0328-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.