Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz.
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 Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz. can. 4 cans per case; 7oz. can. 6 cans per case Item numbers: 64715 64717 64719 Retail UPCs: 070074647128 070074647166 070074647180
- 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-0927-2022
- Quantity
- 1511774 cases
- Distribution
- US Nationwide. Worldwide.
- Initiated
- 17 February 2022
- Reported by FDA
- 16 March 2022
- Firm notified by
- Press Release
- Product codes
- Batches: 33691Z200 33692Z200 34758Z200 34759Z200 34759Z210 34776Z200 34777Z200 34778Z210 34930Z200 34931Z211 34932Z200 35015Z200 35016Z260 35033Z260 35034Z260 36035Z260 36036Z260 36067Z260 36068Z260 36155Z261 32420Z260 23380Z260 24464Z261 24528Z260 24529Z260 24533Z260 24534Z260 25661Z260 25661Z270 25662Z260 25663Z260 25664Z260 25725Z260 26726Z260 26727Z260 26728Z260 26732Z260 26733Z260 26805Z260 26806Z260 26807Z260 27925Z260 27941Z260 27942Z260 27943Z260 28042Z260 28042Z270 28043Z260 28044Z260 29260Z260 29261Z260 29262Z260 29268Z260 29269Z260 29270Z260 29271Z260 30286Z260 30287Z260 30375Z260 30376Z210 30377Z200 30378Z200 30379Z260 30380Z260 30381Z260 30382Z260 32404Z260 32405Z260 32417Z260 32418Z220 32419Z260 32424Z210 32424Z260 32425Z200 33426Z200 33427Z200 33428Z200 33696Z200 33697Z200 22332Z260 24496Z260 25559Z260 26813Z260 27929Z260 28045Z260 30288Z201 30383Z211 30383Z261 30386Z200 30387Z210 31403Z200 32418Z200 32418Z210 23381Z260 23381Z270 23382Z260 25551Z260 25552Z260 25553Z260 25554Z260 25555Z260 25556Z260 26814Z260 26815Z260 26816Z260 27868Z260 27869Z260 27870Z260 28117Z260 28118Z260 28119Z260 28120Z260 28121Z260 28122Z260 28136Z260 28137Z260 28138Z260 29187Z270 29188Z270 29189Z260 29190Z261 29259Z261 31413Z260 31414Z260 31415Z260 33698Z260 33699Z260 33700Z260 33700Z270 33701Z260 35017Z260 35018Z260 35019Z260 35020Z260 35021Z260 35022Z260
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. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 41 of them.
- 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
Salmonella
Salmonella is a bacterium that survives in low-moisture foods for months, which is why it appears in recalls of products that carry no water for it to grow in: nut butters, spices, flour and dry pet food.
A preventive controls plan covers Salmonella contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.135(c)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 117.165(a)(2)
- Product testing: testing as a verification activity, appropriate to the facility, the food and the nature of the preventive control.
Filed under infant formula and baby food. A product can sit in more than one.
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
21 CFR 117.135(c)(1) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.