Abbott Similac Pro-Advance Infant Formula with Iron 20.6oz. and 23.2oz. plastic jar.
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 Pro-Advance Infant Formula with Iron 20.6oz. and 23.2oz. plastic jar. 4 jars per case; 34oz. plastic jar. 6 jars per case; 7oz. can. 6 cans per case. Item numbers: 66081 66655 67922 68088 Retail UPCs: 070074660806 070074666563 070074679167 070074680897
- 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-0931-2022
- Quantity
- 1728823 cases
- Distribution
- US Nationwide. Worldwide.
- Initiated
- 17 February 2022
- Reported by FDA
- 16 March 2022
- Firm notified by
- Press Release
- Product codes
- Batches: 23407SH00 23409SH00 24460SH00 24480SH00 24523SH00 24524SH00 25598SH00 25600SH00 25694SH00 25695SH00 25736SH00 25780SH00 26762SH00 26764SH00 26831SH00 26833SH00 27886SH10 23375SH00 23376SH00 23430SH00 23431SH00 24456SH00 24457SH00 24458SH00 24459SH00 24490SH00 24526SH00 24615Sh00 24615SH10 25570SH00 25586SH00 25652SH00 25653SH00 26749SH00 26750SH00 26752SH00 26759SH00 26761SH00 26824SH00 26825SH00 26826SH00 26827SH00 26828SH00 26829SH00 26841SH00 26843SH00 27881SH00 27882SH00 27883SH00 27884SH00 29181SH00 29182SH00 29225SH00 29226SH00 29228SH00 29295SH00 29296SH00 29297SH00 30308SH00 31457SH00 31459SH00 31460SH00 31462SH00 31483SH00 31484SH00 31486SH10 31488SH00 31490SH00 31492SH00 31493SH10 31493SH11 31494SH00 31550SH00 31551SH00 31577SH00 31578SH00 32616SH00 32618SH00 32668SH00 32669SH00 32670SH00 33736SH00 34798SH00 34960SH00 34961SH00 35039SH00 35040SH00 35041SH00 35042SH00 35198SH00 35962SH00 35963SH00 35964SH00 35965SH00 35966SH00 35967SH00 35968SH00 35969SH00 35970SH00 35971SH00 35972SH00 35973SH00 36189SH00 36190SH00 36191SH00 36193SH00 36194SH00 36195SH00 36196SH00 36219SH00 36220SH00 36221SH00 36222SH00 36223SH00 36224SH00 23401K800 23402K800 24479K800 25595K800 26842K800 27886K800 27957K800 27958K800 27959K800 27960K800 28012K800 28092K800 28103K800 28106K800 29185K800 30325K800 30326K800 30441K800 30441K810 30442K800 33717K800 33718K800 33779K800 33782K800 27974SH00 27975SH00 27976SH00 27991SH00 28008SH00 28010SH00 28104SH00 28105SH00 28156SH00 28157SH00 29206SH00 29222SH00 30305SH00 30306SH00 30307SH00 30340SH00 30341SH00 30342SH00 30362SH00 30363SH00 30369SH00 31481SH00 31482SH00 31573SH00 31575SH00 31576SH00 32590SH00 32591SH00 34810SH00 34812SH00 34812SH10 35060SH00 35061SH00 35082SH00 35082SH01 35083SH00 35084SH00 35990SH00 35991SH00 36134SH00 36135SH00 37292SH00 37293SH00
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.