Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 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 Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac Pro-Advance 34oz. plastic jar. 6 jars per case. Item numbers: 53359 68084 5595776 6748701 Retail UPCs: 070074533605 070074680859 070074559582 070074122373
- 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-0935-2022
- Quantity
- 3491684 cases
- Distribution
- US Nationwide. Worldwide.
- Initiated
- 17 February 2022
- Reported by FDA
- 16 March 2022
- Firm notified by
- Press Release
- Product codes
- Batches: 23432SH00 23433SH00 24461SH00 24462SH00 25593SH00 25594SH00 25596SH00 26765SH00 26766SH00 26795SH00 26796SH00 27001SH00 27003SH00 27996SH00 27997SH00 27998SH00 28025SH00 28111SH00 29229SH00 29230SH00 30359SH00 31585SH00 31587SH00 31588SH00 35059SH00 35072SH00 37245SH00 23403K800 23404K800 23406K800 23408K800 23410K800 23434K800 23435K800 23436K800 23437K800 24473K800 24474K800 24475K800 24476K800 24477K800 24478K800 24491K800 24492K800 24512K800 24513K800 24514K800 24518K800 24519K800 24520K800 24521K800 24522K800 25578K800 25580K800 25581K800 25582K800 25583K800 25584K800 25585K800 25597K800 25599K800 25601K800 25602K800 25603K800 25666K800 25669K800 25670K800 25671K800 25672K800 25680K800 25696K800 25697K800 25698K800 25699K800 26751K800 26753K800 26754K800 26755K800 26757K800 26757K801 26758K800 26775K800 26776K800 26792K800 26793K800 26794K800 26844K800 26845K800 26846K800 26847K800 26848K800 26849K800 26850K800 26851K800 27002K800 27894K800 27895K800 27896K800 27897K800 27898K800 27899K800 27900K800 27901K800 27902K800 27903K800 27904K800 27905K800 27906K800 27907K800 27908K800 27909K800 27962K800 27963K800 27964K800 27965K800 27966K800 27967K800 27968K800 27969K800 27969K810 27970K800 27999K800 28004K800 28005K800 28006K800 28007K800 28009K800 28011K800 28028K800 28030K800 28084K800 28085K800 28093K800 28094K800 28095K800 28107K800 28108K800 28109K800 28110K800 28112K800 28113K800 28114K800 28115K800 28116K800 28149K800 28150K800 28151K800 29196K800 29197K800 29198K800 29199K800 29200K800 29207K800 29208K800 29221K800 29223K800 29224K800 29227K800 29250K800 29251K800 29252K800 29253K800 29254K800 29255K800 29256K800 29257K800 30310K800 30324K800 30346K800 30347K800 30348K800 30350K800 30352K800 30354K800 30366K800 30367K800 30368K800 30370K800 30371K800 30373K800 31477K800 31479K800 31485K800 31487K800 31489K800 31491K800 31505K800 31506K800 32596K800 32621K800 32622K800 32623K800 32634K800 32635K800 32637K800 32678K800 32679K800 33786K800 33787K800 33788K800 33789K800 33790K800 33791K800 33832K800 33833K800 34793K800 34795K800 34797K800 34811K800 34813K800 34814K800 34816K800 34817K800 34818K800 34819K800 34820K800 34852K810 34853K810 34863K800 34864K800 34875K800 34876K800 34877K800 34878K800 34879K800 34880K800 34881K800 34882K800 34883K800 34936K800 34937K800 34938K800 34939K800 34941K800 34942K800 34951K800 34952K800 34953K800 34954K800 35070K800 35071K800 35984K800 35985K800 35986K800 36087K800 36140K800 36141K800 36142K800 36143K800 36225K800 36226K800 36227K800 36228K800 37242K800 37243K800 32640SH00 23405SH00 23405SH01 24527SH00 24569SH00 25693SH00 26836SH00 27880SH00 28147SH00 28148SH00 29183SH00 29184SH00 32593SH00 37246SH00 37247SH00 37248SH00 37249SH00 37250SH00 37309SH00 37310SH00
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.