Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive…
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 Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive Infant Formula with Iron 12.5oz. can and 20.1oz. plastic jar. 6 units per case. Item numbers: 68082 5753978 6748901 674891L Retail UPCs: 070074680835 070074575414 070074122380
- 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-0938-2022
- Quantity
- 2046814 cases
- Distribution
- US Nationwide. Worldwide.
- Initiated
- 17 February 2022
- Reported by FDA
- 16 March 2022
- Firm notified by
- Press Release
- Product codes
- Batches: 28015SH00 28013SH00 28016SH00 28018SH00 28019SH00 30302SH00 30447SH00 30449SH00 32610SH00 36214SH00 36215SH00 23390K800 23392K800 23422K800 23423K800 23424K800 23425K800 23428K800 23429K800 24454K800 24455K800 24483K800 24484K800 24485K800 24486K800 24487K800 24488K800 24504K800 24505K800 24506K800 24517K800 25591K800 25592K800 25678K800 25678K801 25679K800 25734K800 25735K800 26741K800 26743K800 26745K800 26788K800 26789K800 27879K800 27892K800 27893K800 27947K800 27948K800 27949K800 27950K800 27952K800 28020K800 28021K800 28022K800 28099K800 28100K800 28101K800 28142K800 28143K800 28144K800 28145K800 28146K800 29191K800 29192K800 29193K800 29194K800 29195K800 29234K800 29235K800 29236K800 29293K800 29294K800 30300K800 30301K800 30322K800 30323K800 30338K800 30339K800 30356K800 30357K800 30358K800 30360K800 30361K800 30444K800 30446K800 30448K800 30450K800 30451K800 30452K800 31471K800 31472K800 31473K800 31474K800 32619K800 32620K800 32627K800 32628K800 32629K800 32630K800 32631K800 32632K800 32633K800 32680K800 32681K800 32682K800 33705K800 33709K800 33710K800 33711K800 33712K800 33713K800 33714K800 33715K800 33724K800 33735K800 33830K800 33831K800 34850K800 34850K801 34851K800 34858K810 34859K810 34862K800 34871K800 34872K800 34873K800 34874K800 34945K800 34946K800 34947K800 34948K800 34949K800 34950K800 35051K800 35052K800 35074K800 35075K800 35197K800 35976K800 35977K800 35978K800 36091K800 36093K800 36094K800 36096K800 36128K800 36129K800 36130K800 36131K800 36132K800 36133K800 37279K800 37279K801 37280K800 37281K800 37282K800 37322K800 37428K800 37429K800 25682SH00 27878SH00 28090SH00 29205SH00 29244SH00 31501SH00 32615SH00 32617SH00 34807SH00 34851SH00 36116SH00 26839SH00
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.