FDA recall record

Abbott Similac Total Comfort 638g recall — FDA F-0928-2022

Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility…

Class Iclassification
F-0928-2022official record ID
Mar 16, 2022report date

Recall record at a glance

Official recordF-0928-2022
CategoryFood Recalls
ClassificationClass I
FDA record statusOngoing
Recalling firmAbbott Laboratories
Report dateMar 16, 2022
Recall initiation dateFeb 17, 2022
Quantity109848 cases
LocationAbbott Park, IL, United States

Official product description

Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per case. Abbott Similac Advance Step-2 34oz. can. 6 cans per case. Item numbers: 6635013 6635113 6698413 Retail UPCs: 055325626602 055325626626 055325001652

Why the product 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

Distribution information

US Nationwide. Worldwide.

How to read the classification

FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Press Release.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.

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