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Abbott Laboratories

FEI 1415939 · United States

Per FDA, as of 2026-10-31 · Sources: FDA Data Dashboard, Import Alerts, Enforcement Reports

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Import alerts
0
Import refusals (5 years)
0
Warning letters
0
Last FDA action
2022-02-17
4 years ago

FDA record

  1. 2022-02-17
    RecallRecall F-0918-2022 · Class 1 · 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
    Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591
    Source: FDA Enforcement Reports
  2. 2022-02-17
    RecallRecall F-0919-2022 · Class 1 · 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
    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 0553255459…
    Source: FDA Enforcement Reports
  3. 2022-02-17
    RecallRecall F-0920-2022 · Class 1 · 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
    Abbott Similac Alimentum Toddler Drink 12.1oz. can. 6 cans per case. Item numbers: 68398 Retail UPCs: 070074683997
    Source: FDA Enforcement Reports
  4. 2022-02-17
    RecallRecall F-0921-2022 · Class 1 · 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
    Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item numbers: 6259962 Retail UPCs: 070074119953
    Source: FDA Enforcement Reports
  5. 2022-02-17
    RecallRecall F-0922-2022 · Class 1 · 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
    Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per case. Item numbers: 63013 Retail UPCs: 070074629506 70074629506
    Source: FDA Enforcement Reports
  6. 2022-02-17
    RecallRecall F-0923-2022 · Class 1 · 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
    Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 Retail UPCs: 070074537306
    Source: FDA Enforcement Reports
  7. 2022-02-17
    RecallRecall F-0924-2022 · Class 1 · 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
    Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per case. Item numbers: 6499213 6698213 Retail UPCs: 055325000808 055325001638
    Source: FDA Enforcement Reports
  8. 2022-02-17
    RecallRecall F-0925-2022 · Class 1 · 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
    Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. Abbott Similac Advance 34oz. can. 6 cans per case. Abbott Similac Pro-Advance 20.6oz. and 859g. plastic jar. 6 jars per case. Item numbers: 6499113 6698313 6818113…
    Source: FDA Enforcement Reports
  9. 2022-02-17
    RecallRecall F-0926-2022 · Class 1 · 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
    Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic jar. 6 jars per case. Item numbers: 6499813 Retail UPCs: 055325001218
    Source: FDA Enforcement Reports
  10. 2022-02-17
    RecallRecall F-0927-2022 · Class 1 · 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
    Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz. can. 4 cans per case; 7oz. can. 6 cans per case Item numbers: 64715 64717 64719 Retail UPCs: 070074647128 070074647166 070074647180
    Source: FDA Enforcement Reports
  11. 2022-02-17
    RecallRecall F-0928-2022 · Class 1 · 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
    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 05532500165…
    Source: FDA Enforcement Reports
  12. 2022-02-17
    RecallRecall F-0929-2022 · Class 1 · 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
    Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans per case Item numbers: 6676006 6676012 6676021 6676025 6676030 6676045 6676053 6676057 Retail UPCs: 86…
    Source: FDA Enforcement Reports
  13. 2022-02-17
    RecallRecall F-0930-2022 · Class 1 · 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
    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: 070074660…
    Source: FDA Enforcement Reports
  14. 2022-02-17
    RecallRecall F-0931-2022 · Class 1 · 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
    Abbott Similac Pro-Advance Infant Formula with Iron 20.6oz. and 23.2oz. plastic jar. 4 jars per case; 34oz. plastic jar. 6 jars per case; 7oz. can. 6 cans per case. Item numbers: 66081 66655 67922 68088 Retail UPCs: 07007466080…
    Source: FDA Enforcement Reports
  15. 2022-02-17
    RecallRecall F-0932-2022 · Class 1 · 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
    Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail UPCs: 055325002567 055325002581
    Source: FDA Enforcement Reports
  16. 2022-02-17
    RecallRecall F-0933-2022 · Class 1 · 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
    Abbott Similac Pro-Advance 20.6oz., 30.3oz., 34oz., and 658g plastic jar. 6 jars per case. 7oz. can. 6 cans per case. Item numbers: 6720113 6720813 6726613 6818013 6818213 6832313 Retail UPCs: 055325002499 055325002543 0553…
    Source: FDA Enforcement Reports
  17. 2022-02-17
    RecallRecall F-0934-2022 · Class 1 · 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
    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: 070074…
    Source: FDA Enforcement Reports
  18. 2022-02-17
    RecallRecall F-0935-2022 · Class 1 · 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
    Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac Pro-Advance 34oz. plastic jar. 6 jars per case. Item numbers: 53359 68084 5595776 6748701 …
    Source: FDA Enforcement Reports
  19. 2022-02-17
    RecallRecall F-0936-2022 · Class 1 · 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
    Abbott Alimentum, Abbott Similac Alimentum, Abbott Similac Alimentum HMO, Abbott Alimentum Similac, Abbott Similac Gold Alimentum HMO 400g can. 6 cans per case. Item numbers: 674845 6748406 6748408 6748412 6748425 6748426 674843…
    Source: FDA Enforcement Reports
  20. 2022-02-17
    RecallRecall F-0937-2022 · Class 1 · 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
    Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 Retail UPCs: 070074508184
    Source: FDA Enforcement Reports
  21. 2022-02-17
    RecallRecall F-0938-2022 · Class 1 · 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
    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: 0…
    Source: FDA Enforcement Reports
  22. 2022-02-17
    RecallRecall F-0939-2022 · Class 1 · 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
    Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UPCs: 070074626000
    Source: FDA Enforcement Reports
  23. 2022-02-17
    RecallRecall F-0940-2022 · Class 1 · 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
    Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per case. Item numbers: 5095976 Retail UPCs: 070074509600
    Source: FDA Enforcement Reports
  24. 2022-02-17
    RecallRecall F-0941-2022 · Class 1 · 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
    Abbott Similac For Spit Up Infant Formula with Iron 7oz. can and 19.5oz. plastic jar. 6 units per case. Item numbers: 67927 68086 Retail UPCs: 070074679280 070074680873
    Source: FDA Enforcement Reports
  25. 2022-02-17
    RecallRecall F-0942-2022 · Class 1 · 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
    Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum infant formula, Abbott Similac Alimentum 400g can. 6 cans per case. Item numbers: 6749111 6749117 6749118 6749124…
    Source: FDA Enforcement Reports
  26. 2022-02-17
    RecallRecall F-0943-2022 · Class 1 · 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
    Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palstic jar. 4 jars per case. 7oz. can. 6 cans per case. Item numbers: 68063 68065 68109 Retail UPCs: 070074680644 070074680668 070074681108
    Source: FDA Enforcement Reports
  27. 2022-02-17
    RecallRecall F-0944-2022 · Class 1 · 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
    Abbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar. 4 jars per case. Abbott Similac Organic Toddler with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. Item numbers: 67905 68104 Retail UP…
    Source: FDA Enforcement Reports
  28. 2022-02-17
    RecallRecall F-0945-2022 · Class 1 · 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
    Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Organic with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. 23.2oz plastic jar. 6 jars per case. Item numbers: 68013 68092 5082178 Reta…
    Source: FDA Enforcement Reports
  29. 2022-02-17
    RecallRecall F-0946-2022 · Class 1 · 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
    Abbott Similac Organic with A2 Milk Infant Formula with Iron 8oz. and 7oz. can. 6 cans per case. 20.6oz. plastic jar. 4 jars per case. Item numbers: 67904 68016 68099 Retail UPCs: 070074677545 070074680170 070074681009
    Source: FDA Enforcement Reports
  30. 2022-02-17
    RecallRecall F-0947-2022 · Class 1 · 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
    Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 cans per case. 20.1oz. and 29.5oz. plastic jar. 4 jars per case. Item numbers: 68070 68072 68118 Retail UPCs: 070074680712 070074680736 070074681191
    Source: FDA Enforcement Reports
  31. 2022-02-17
    RecallRecall F-0948-2022 · Class 1 · 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
    Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans per case. Item numbers: 5351034 5351066 5351039 5351077 Retail UPCs: 17703186031461 9340104000706 17501033957748 070074119281
    Source: FDA Enforcement Reports
  32. 2022-02-17
    RecallRecall F-0949-2022 · Class 1 · 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
    Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron 14.1oz. can, Abbott Elecare 400g. can, Abbott Elecare Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55251 5525157 5525189 Retail UPCs: 070074535111 07007…
    Source: FDA Enforcement Reports
  33. 2022-02-17
    RecallRecall F-0950-2022 · Class 1 · 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
    Abbott EleCare Junior Vanilla 14.1oz. can and Abbott EleCare Jr Similac Vanilla 14.1oz. can. 6 cans per case. Item numbers: 56585 5658557 Retail UPCs: 070074565866 070074116723
    Source: FDA Enforcement Reports
  34. 2022-02-17
    RecallRecall F-0951-2022 · Class 1 · 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
    Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55253 Retail UPCs: 070074552545 70074552545
    Source: FDA Enforcement Reports
  35. 2022-02-17
    RecallRecall F-0952-2022 · Class 1 · 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
    Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 Retail UPCs: 070074662763
    Source: FDA Enforcement Reports
  36. 2022-02-17
    RecallRecall F-0953-2022 · Class 1 · 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
    Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz. can. 6 cans per case. Item numbers: 66273 Retail UPCs: 070074662718
    Source: FDA Enforcement Reports
  37. 2022-02-17
    RecallRecall F-0954-2022 · Class 1 · 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
    Abbott Similac Alimentum 400g. can. 6 cans per case. Item numbers: 5705806 Retail UPCs: 8699548994869
    Source: FDA Enforcement Reports
  38. 2022-02-17
    RecallRecall F-0955-2022 · Class 1 · 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
    Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: 5707713 Retail UPCs: 055325000624
    Source: FDA Enforcement Reports
  39. 2022-02-17
    RecallRecall F-0956-2022 · Class 1 · 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
    Abbott Similac Alimentum Eye Q Plus 400g. can. Abbott Alimentum Eye Q 400g. can. Abbott Alimentum Eye Q Hypoallergenic 400g. can. 6 cans per case. Item numbers: 6208407 6208418 6208481 6208482 6208483 Retail UPCs: 07007411043…
    Source: FDA Enforcement Reports
  40. 2022-02-17
    RecallRecall F-0957-2022 · Class 1 · 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
    Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: Clinical Retail UPCs: N/A - Clinical
    Source: FDA Enforcement Reports
  41. 2022-02-17
    RecallRecall F-0958-2022 · Class 1 · 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
    Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans per case. Item numbers: 00850 Retail UPCs: 070074608501
    Source: FDA Enforcement Reports
  42. 2019-09-13
    RecallRecall F-0022-2020 · Class 2 · Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.
    Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
    Source: FDA Enforcement Reports