Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum…

Abbott Laboratories recalled this product and the FDA reported the enforcement action on 16 March 2022 as Class I. The recall was initiated by the firm. Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced

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

Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum infant formula, Abbott Similac Alimentum 400g can. 6 cans per case. Item numbers: 6749111 6749117 6749118 6749124 6749134 6749166 6749181 6749199 Retail UPCs: 070074124476 070074124438 0070074124490 070074124414 7703186029294 7501033958175 0070074122427 070074122441

Reason for recall

Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced

Recalling firm

Abbott Laboratories

Firm location

Abbott Park, Illinois, United States

Classification

Class I

Status

Ongoing

Recall number

F-0942-2022

Quantity

34704 cases

Distribution

US Nationwide. Worldwide.

Initiated

17 February 2022

Reported by FDA

16 March 2022

Firm notified by

Press Release

Product codes

Batches: 36146Z265 34768Z201 35014Z201 36146Z264 35014Z202 36146Z261 29284Z260 32416Z201 34768Z200 36146Z263 27938Z260 29284Z261 32416Z200 35014Z200 36146Z260 36146Z262 27938Z261 29284Z262 34768Z202

Reading this record

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

• Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 is one of 41 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 41 separate recalls, which almost every published figure does, overstates it by a factor of 41. All 41 of them are listed on this page.
• This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
• The FDA published the enforcement report 4 weeks after the firm began the recall.
• Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.

What this recall was for

Filed under infant formula and baby food. A product can sit in more than one.

Every product in this recall

The FDA opened 41 enforcement records for this one recall, one per product code. This page carries all of them; the 40 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

Other infant formula and baby food recalls for the same reason

These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. 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 2022 recalls · All FDA food recall data