Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case I
Summary
The FDA issued a Class I for Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per r by Abbott Laboratories. Reason: Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil.
Details
Source
Food Recall
External ID
F-0919-2022
Action Date
2022-03-16
Status
Ongoing
Category
food
Product Description
Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 54598 5459813 5459814 5459820 5459886 6771009 Retail UPCs: 70074545998 070074545998 055325545996 070074109404 070074103297 070074671833
Lot/Code Info: Batches: 22349Z200 25609Z200 26914Z200 26915Z200 26916Z200 26917Z200 26918Z200 26919Z200 26920Z200 26921Z200 27073Z200 28077Z200 28158Z200 28162Z200 28166Z200 29385Z200 30512Z200 30513Z200 30521Z200 31525Z200 31533Z200 31534Z200 31543Z200 32649Z200 32655Z200 32656Z200 32660Z200 32660Z210 32671Z200 33751Z200 33752Z200 34045Z200 34046Z210 34892Z200 34901Z200 35112Z200 35113Z200 35163Z200 36170Z200 30522Z200 32657Z200 22353Z200 22354Z200 26782Z200 26785Z200 27982Z200 27983Z200 31541Z200 33753Z200 34890Z200 34891Z200 35164Z200 36171Z200 24472Z200 25610Z200 27984Z200 32672Z200 32673Z200 32674Z200 22296Z200 22297Z200 25712Z200 26781Z200 26786Z200 26787Z200 30514Z200 30523Z200 31524Z200 31532Z200 31542Z200 32658Z200 33659Z200 33756Z200 33757Z200 34889Z200 36169Z200 22350Z200 22351Z200 22352Z200 22355Z200 22356Z200 22357Z200 23358Z200 23359Z200 24465Z200 24466Z200 24467Z200 24468Z200 24469Z200 24470Z200 24471Z200 25605Z200 25606Z200 25607Z200 25608Z200 25611Z200 25612Z200 25613Z200 25614Z200 25705Z200 25706Z200 25707Z200 25708Z200 25709Z200 25710Z200 25711Z200 25713Z200 25714Z200 26772Z200 26777Z200 26778Z200 26779Z200 26783Z200 26784Z200 26852Z200 26853Z200 27074Z200 27854Z200 27855Z200 27856Z200 27857Z200 27985Z200 27986Z200 28075Z200 28078Z200 28079Z200 28080Z200 28159Z200 28160Z200 28161Z200 28163Z200 28164Z200 28165Z200 30515Z200 30516Z200 30519Z200 30520Z200 31526Z200 31527Z200 31528Z200 31529Z200 31530Z200 31531Z200 31535Z200 31536Z200 31537Z200 31538Z200 31539Z200 31540Z200 32650Z200 32651Z200 32652Z200 32653Z200 32654Z200 32675Z200 33661Z200 33743Z200 33744Z200 33745Z200 33746Z200 33747Z200 33748Z200 33749Z200 33750Z200 33754Z200 33755Z200 33885Z200 33886Z200 34043Z200 34044Z200 34887Z200 34888Z200 34893Z200 34894Z200 34895Z200 34896Z200 34897Z200 34898Z200 34899Z200 34900Z200 34902Z200 34903Z200 34904Z200 34905Z200 35110Z200 35111Z200 28076Z200
Quantity Affected: 104146 cases
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
Distribution
US Nationwide. Worldwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-17
Company
Abbott Park, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 92 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0919-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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