Abbott Similac Pro-Sensitive Infant Formula with Iron 20.1oz. and 22.5oz. 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-Sensitive Infant Formula with Iron 20.1oz. and 22.5oz. plastic jar. 4 jars per case; 34oz. plastic jar. 6 jars per case; 7oz. can. 6 cans per case. Item numbers: 66084 66657 67923 68090 Retail UPCs: 070074660820 070074666587 070074679242 070074680910
- 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-0930-2022
- Quantity
- 938215 cases
- Distribution
- US Nationwide. Worldwide.
- Initiated
- 17 February 2022
- Reported by FDA
- 16 March 2022
- Firm notified by
- Press Release
- Product codes
- Batches: 23421SH00 24509SH00 24510SH00 24567SH00 24568SH00 25589SH00 25590SH00 25689SH00 26740SH00 26742SH00 26744SH00 24452SH00 24453SH00 24507SH00 24508SH00 25573SH00 25574SH00 25576SH00 25648SH00 25649SH00 26746SH00 26790SH00 26822SH00 26823SH00 27876SH00 27877SH00 29201SH00 29202SH00 29203SH00 29204SH01 29218SH00 29218SH01 29233SH00 29298SH00 29299SH00 30336SH00 31455SH00 31456SH00 31499SH00 31500SH00 32636SH00 32638SH00 33731SH00 33732SH00 33734SH00 34802SH00 34804SH00 35037SH00 35038SH00 35047SH00 35048SH00 35979SH00 35980SH00 35992SH00 35993SH00 36186SH00 36187SH00 36188SH00 36199SH00 36200SH00 25575K800 27953K800 27955K800 28023K800 28175K800 28176K800 29241K800 30320K800 30321K800 30337K800 31458K800 31589K800 33716K800 33733K800 27979SH00 27980SH00 27981SH00 28102SH00 28102SH10 28154SH00 28155SH00 28155SH01 28177SH00 29231SH00 29232SH00 30443SH00 30445SH00 31453SH00 32639SH00 35009SH00 35010SH00 35053SH00 35054SH00 35078SH00 35079SH00 35080SH00 36216SH00
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.