Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case.
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 Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UPCs: 070074626000
- 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-0939-2022
- Quantity
- 1226623 cases
- Distribution
- US Nationwide. Worldwide.
- Initiated
- 17 February 2022
- Reported by FDA
- 16 March 2022
- Firm notified by
- Press Release
- Product codes
- Batches: 24449K800 24449K801 24450K800 24482K800 24515K800 24516K800 24566K800 24566K801 25571K800 25571K801 25650K800 25651K800 25687K800 25688K800 26747K800 26748K800 26817K800 26818K800 26819K800 26830K800 26832K800 26834K800 26835K800 27888K800 27889K800 27890K800 27891K800 27951K800 28017K800 28086K800 28088K800 28098K800 28178K800 28179K800 28179K801 28180K800 29219K800 29220K801 29237K800 29238K800 30314K800 30316K800 30317K800 31467K800 31468K800 31469K800 31470K800 31584K800 31586K800 32609K800 32611K800 32612K800 33706K800 33706K801 33707K800 33708K800 34073K800 34800K800 34801K800 34844K800 34844K801 34845K800 34846K800 34847K800 34865K800 34866K800 34867K800 34868K800 34869K800 34870K800 34943K800 34944K800 35981K800 35982K800 35983K800 36086K800 36121K800 36122K800 36212K800 36213K800 37238K800 37239K800 37240K800 37241K800 37298K800 37299K800 37300K800 37301K800 37302K800 37430K800 37431K800
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.