Class IF-0934-2022

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

Product

Abbott Similac Pro-Total Comfort 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: 66798 66939 67925 68107 Retail UPCs: 070074667997 070074669403 070074679266 070074681085

Type: Food
Affected lot / code info: Batches: 26838SH00 26860SH00 26861SH00 30318SH00 31498SH00 31580SH00 33730SH00 24451SH00 24565SH00 26738SH00 26791SH00 23495K800 24481K800 25572K800 25588K800 26739K800 26837K800 28014K800 28141K800 28152K800 29243K800 29246K800 30319K800 31466K800 31579K800 31581K800 32613K800 32614K800 34860K800 36123K800 37236K800 27977SH00 27978SH00 27990SH00 28096SH00 28097SH00 30303SH00 30304SH00 31582SH00 31583SH00 33726SH00 33727SH00 33728SH00 33729SH00 37237SH00 37303SH00
Quantity: 766561 cases

Why it was recalled

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

Firm: Abbott Laboratories
Notification channel: Press Release
Type: Voluntary: Firm initiated
Address: 100 Abbott Park Rd Bldg Ap8b, N/A, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: US Nationwide. Worldwide.

Timeline

Recall initiated: 2022-02-17
FDA classified: 2022-03-30
Posted by FDA: 2022-03-16
Status: Ongoing

Source: openFDA Food Enforcement endpoint. Recall record F-0934-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.