Abbott Laboratories FDA recall records

The FDA has published 61 food recall enforcement records naming Abbott Laboratories between 2015 and 2023, covering 9 separate recall events. The firm is recorded in Ohio. Data last updated 2 September 2026.

Records of 29,386
61
Share of all recalls
0.2%
Class I of 61
41
Reported between
2015 to 2023

What is different about Abbott Laboratories

The hazard that separates Abbott Laboratories from the national picture is salmonella: 67.2% of these records name it, against 12.4% of all FDA food recalls.

By product, Abbott Laboratories is weighted toward infant formula and baby food: 41% of the records here against 0.3% across the corpus.

Recalls at Abbott Laboratories are more often the serious kind: 67.2% are Class I, where the FDA judges there is a reasonable probability of serious health consequences, against 44% of all records.

A recall at Abbott Laboratories stays open a median of 671 days between the report and termination, against 215 days for the corpus as a whole. Termination follows the firm accounting for every unit of the affected lot.

These recalls travel further than most: 68.9% state nationwide distribution, against 20.7% of all records.

A single recall here covers far more records than usual: 6.8 enforcement records per FDA event, against 3.7 across the corpus. The agency opens one record per product code, so this is a sign of broad product lines rather than of repeated failures.

What these records are

Every record on this page was published by the FDA in the openFDA food enforcement database. 61 records cover 9 recall events, because the agency opens one record per product code: a single recall of a product line with many codes appears here many times.

41 of these records are Class I, 19 Class II and 1 Class III. A recall count is not a safety score. Most FDA food recalls are initiated by the firm itself, and a recall is the firm removing product from the market, which is what a food safety plan is built to produce.

What was recalled for

A single record can name more than one hazard, so these counts overlap.

By year

Counts are by the date the FDA reported the enforcement action. That date runs behind the date a firm started a recall, so the most recent year is always partial.

Where the recalling firms are

The state is the location of the recalling firm, not where the product was sold. Distribution is recorded separately on each record.

Most recently reported

The 60 most recent of 61 records. Every record has its own page and is reachable from its year, state and firm.
ReportedProductFirmReasonClass
2023-11-15Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.Abbott LaboratoriesMarketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additiveClass II
2023-04-19Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard cartonAbbott LaboratoriesPotential of foreign material (hard plastic) within productClass II
2022-11-23Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kitAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count cartonAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count cartonAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-11-23Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count caseAbbott LaboratoriesCompromised seal integrity which could lead to spoilageClass II
2022-08-31Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL OZ (1L) Bottles 270 FL OZ (8L) Liter UPC: 7007462681 62681Abbott LaboratoriesPotential leaking/pinholes in bottleClass II
2022-06-29Pedialyte 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 USAAbbott LaboratoriesThese products are being recalled due to the potential of leakage from the 1L container.Class II
2022-06-29Pedialyte 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 USAAbbott LaboratoriesThese products are being recalled due to the potential of leakage from the 1L container.Class II
2022-06-22Pedialyte***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***Manufactured for: Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219Abbott LaboratoriesThe 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.Class III
2022-03-16Abbott 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 Retail UPCs: 070074533605 070074680859 070074559582 070074122373Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 6748430 6748453 6748484 Retail UPCs: 0070074122250 8699548994869 070074122311 0070074124131 070074122359 070074122274 070074123349 070074123325Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per case. Item numbers: 63013 Retail UPCs: 070074629506 70074629506Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail UPCs: 055325002567 055325002581Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 Retail UPCs: 070074537306Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 070074671833Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 070074680873Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 Retail UPCs: 070074680156 070074680934 070074508221Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 Retail UPCs: 070074508184Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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: 070074680835 070074575414 070074122380Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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: 070074110431 070074123905 070074110356 070074111834 070074110271Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 6818313 Retail UPCs: 055325000808 055325001645 055325002864 055325002888Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 055325002604 055325002819 055325002833 055325003069Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 070074681191Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: 5707713 Retail UPCs: 055325000624Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per case. Item numbers: 6499213 6698213 Retail UPCs: 055325000808 055325001638Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 UPCs: 070074677576 070074681054Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 055325001652Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item numbers: 6259962 Retail UPCs: 070074119953Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac Alimentum 400g. can. 6 cans per case. Item numbers: 5705806 Retail UPCs: 8699548994869Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UPCs: 070074626000Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz. can. 6 cans per case. Item numbers: 66273 Retail UPCs: 070074662718Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 070074681108Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 Retail UPCs: 070074662763Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per case. Item numbers: 5095976 Retail UPCs: 070074509600Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 070074681085Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 6749134 6749166 6749181 6749199 Retail UPCs: 070074124476 070074124438 0070074124490 070074124414 7703186029294 7501033958175 0070074122427 070074122441Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 070074116297 070074119854Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 070074116723Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans per case. Item numbers: 5351034 5351066 5351039 5351077 Retail UPCs: 17703186031461 9340104000706 17501033957748 070074119281Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic jar. 6 jars per case. Item numbers: 6499813 Retail UPCs: 055325001218Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55253 Retail UPCs: 070074552545 70074552545Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac Alimentum Toddler Drink 12.1oz. can. 6 cans per case. Item numbers: 68398 Retail UPCs: 070074683997Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 070074681009Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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: 070074660820 070074666587 070074679242 070074680910Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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: 070074660806 070074666563 070074679167 070074680897Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans per case. Item numbers: 00850 Retail UPCs: 070074608501Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: Clinical Retail UPCs: N/A - ClinicalAbbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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: 8699548995217 0070074124155 0070074123851 0070074120195 070074120850 070074122502 0070074120157Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2022-03-16Abbott 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 070074647180Abbott LaboratoriesConsumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been producedClass I
2019-10-16Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.Abbott LaboratoriesOff color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.Class II

Questions

How many FDA recalls has Abbott Laboratories had?
The FDA has published 61 food recall enforcement records naming Abbott Laboratories between 2015 and 2023. Those records cover 9 separate recall events: the agency opens one record per product code, so one recall of a product line appears as many records.
Does a high recall count mean a firm is unsafe?
Not on its own. Most FDA food recalls are initiated voluntarily by the firm, and a recall is the firm removing product from the market, which is what a working food safety plan is supposed to produce. Record counts also scale with the number of product codes a firm carries rather than with the number of things that went wrong.

All FDA food recall data

A recall is the end of an evidence trail that either existed or did not. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.