Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets.

Abbott Laboratories recalled this product and the FDA reported the enforcement action on 15 November 2023 as Class II. The recall was initiated by the firm. Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product

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

Reason for recall

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

Recalling firm

Abbott Laboratories

Firm location

Columbus, Ohio, United States

Classification

Class II

Status

Terminated

Recall number

F-0328-2024

Quantity

226,650 packets (4,533 cartons)

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, 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

Initiated

31 October 2023

Reported by FDA

15 November 2023

Terminated

3 September 2024

Firm notified by

E-Mail

Product codes

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

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

• Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
• The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
• This record is the only one the FDA opened for its recall event, so it covers a single product code.
• The recall ran for 10 months, from 31 October 2023 to termination on 3 September 2024. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
• The FDA published the enforcement report 2 weeks after the firm began the recall.
• Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.

Filed under dietary supplements. A product can sit in more than one.

Other dietary supplements recalls

These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

Other records from Abbott Laboratories

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 60 other records name this firm.

All 61 records for Abbott Laboratories

All 2023 recalls · All FDA food recall data