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Abbott Laboratories

FEI 3013324964 · 2900 Easton Square Pl, Columbus, Ohio, 43219, 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
2026-06-09
4 months ago

FDA record

  1. 2026-06-09
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Foodborne Biological Hazards
    FDA source
  2. 2025-08-01
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Foodborne Biological Hazards
    FDA source
  3. 2025-08-01
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  4. 2024-06-04
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Foodborne Biological Hazards
    FDA source
  5. 2024-05-10
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  6. 2023-10-31
    RecallRecall F-0328-2024 · Class 2 · Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
    Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
    Source: FDA Enforcement Reports
  7. 2023-09-27
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  8. 2023-09-27
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Foodborne Biological Hazards
    FDA source
  9. 2023-03-28
    RecallRecall F-0698-2023 · Class 2 · Potential of foreign material (hard plastic) within product
    Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
    Source: FDA Enforcement Reports
  10. 2022-12-13
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  11. 2022-10-13
    RecallRecall F-0154-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
    Source: FDA Enforcement Reports
  12. 2022-10-13
    RecallRecall F-0155-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
    Source: FDA Enforcement Reports
  13. 2022-10-13
    RecallRecall F-0156-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
    Source: FDA Enforcement Reports
  14. 2022-10-13
    RecallRecall F-0157-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
    Source: FDA Enforcement Reports
  15. 2022-10-13
    RecallRecall F-0158-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
    Source: FDA Enforcement Reports
  16. 2022-10-13
    RecallRecall F-0159-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
    Source: FDA Enforcement Reports
  17. 2022-10-13
    RecallRecall F-0160-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Source: FDA Enforcement Reports
  18. 2022-10-13
    RecallRecall F-0161-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
    Source: FDA Enforcement Reports
  19. 2022-10-13
    RecallRecall F-0162-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
    Source: FDA Enforcement Reports
  20. 2022-10-13
    RecallRecall F-0163-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Source: FDA Enforcement Reports
  21. 2022-10-13
    RecallRecall F-0164-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Source: FDA Enforcement Reports
  22. 2022-10-13
    RecallRecall F-0165-2023 · Class 2 · Compromised seal integrity which could lead to spoilage
    Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Source: FDA Enforcement Reports
  23. 2022-06-03
    RecallRecall F-1343-2022 · Class 2 · These products are being recalled due to the potential of leakage from the 1L container.
    Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIENTS: WATER, DEXTROSE*** Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
    Source: FDA Enforcement Reports
  24. 2022-06-03
    RecallRecall F-1344-2022 · Class 2 · These products are being recalled due to the potential of leakage from the 1L container.
    Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L*** INGREDIENTS: WATER, DEXTROSE***Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
    Source: FDA Enforcement Reports
  25. 2022-06-03
    RecallRecall F-1312-2022 · Class 3 · The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.
    Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ (17g) PACKETS/NET WT. 3.6 OZ (102g)***INGREDIENTS: ANHYDROUSE DEXTROSE, CITRIC ACID, POTASSIUM CITRATE*…
    Source: FDA Enforcement Reports
  26. 2021-07-30
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  27. 2019-07-19
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  28. 2018-09-26
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source
  29. 2017-09-15
    InspectionFDA inspection · Classification: No Action Indicated (NAI)
    Project area: Food Composition, Standards, Labeling and Econ
    FDA source