The Recall Desk

Manufacturer

Abbott Laboratories

86 recalls in our database name Abbott Laboratories as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 86

  • HighFDA (Food)·F-0155-2023·2022-11-23

    Pedialyte Unflavored 2 fl oz bottles recalled due to seal integrity defect

    Abbott Laboratories recalls Pedialyte Unflavored 2 fl oz bottles for compromised seal integrity that could allow spoilage. Affected bottles were distributed across the United States and multiple countries.

    Product
    Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0160-2023·2022-11-23

    Similac Neosure Infant Formula Recalled Due to Compromised Seal Integrity

    Abbott Laboratories is recalling Similac Neosure 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 14.5 million bottles distributed nationwide and internationally are affected.

    Product
    Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0165-2023·2022-11-23

    Similac Water bottles recalled for compromised seal integrity

    Abbott Laboratories is recalling specific lots of Similac Water due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed across the US, territories, and international locations.

    Product
    Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0157-2023·2022-11-23

    Similac 360 Total Care Infant Formula Recalled for Compromised Bottle Seals

    Abbott Laboratories is recalling batches of Similac 360 Total Care and Total Care Sensitive infant formula 2 fl oz discharge kits for compromised seal integrity that could allow spoilage. The affected batch is identified by product code 39480N200 with a Best By date of 04/01/23.

    Product
    Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1660-2022·2022-09-07

    ARCHITECT STAT Troponin-I Reagent Kit Recalled for Insufficient Blocking Agents

    Abbott is recalling one lot of ARCHITECT STAT Troponin-I Reagent Kits due to insufficient heterophilic blocking agents in the conjugate, which may affect test accuracy.

    Product
    ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1575-2022·2022-08-31

    Abbott Jevity Complete Enteral Nutrition Product Recalled for Potential Bottle Leaks

    Abbott Laboratories is recalling Abbott Jevity Complete enteral nutrition products due to potential leaking or pinholes in the bottles. The recall affects 179 cases distributed to healthcare facilities in seven states.

    Product
    Abbott 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 62681
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1455-2022·2022-08-03

    Abbott Alinity c Hemoglobin Reagent Kit may produce falsely elevated test results

    Abbott Laboratories is recalling the Alinity c Hemoglobin Reagent Kit because the ARCHITECT and Alinity c assays can generate falsely elevated Hemoglobin A1c results.

    Product
    REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1454-2022·2022-08-03

    Abbott Hemoglobin A1c Assay Recalled for Falsely Elevated Test Results

    Abbott Laboratories is recalling hemoglobin A1c test reagents used with ARCHITECT and Alinity c analyzers. The assay may produce falsely elevated A1c results, potentially affecting diabetes patient management.

    Product
    REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1456-2022·2022-08-03

    Alinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results

    Abbott Laboratories is recalling Alinity c Hemoglobin Reagent Kits (lots 59801UQ04 and 60763UQ09) due to a potential for falsely elevated hemoglobin A1c test results when used with ARCHITECT and Alinity c analyzers.

    Product
    REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Food)·F-1343-2022·2022-06-29

    Pedialyte with Immune Support Recalled for Potential Container Leakage

    Abbott Laboratories is recalling specific lots of Pedialyte with Immune Support in 1L containers due to potential leakage. Approximately 50,502 2-count cases are affected across 28 states.

    Product
    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
    Category
    Food
    Distribution
    28 states
  • LowFDA (Food)·F-1344-2022·2022-06-29

    Pedialyte Immune Support Raspberry Lemonade recalled for container leakage risk

    Abbott Laboratories is recalling approximately 121,918 cases of Pedialyte with Immune Support Raspberry Lemonade due to potential container leakage. The recall affects multiple states.

    Product
    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
    Category
    Food
    Distribution
    28 states
  • HighFDA (Food)·F-1312-2022·2022-06-22

    Pedialyte Strawberry Lemonade Powder Recalled for Undeclared Wheat Allergen

    Abbott Laboratories recalls one lot of Pedialyte Strawberry Lemonade powder because dextrose derived from wheat was not declared on the label. Lot code 287112S00.

    Product
    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***Manufactured for: Abbott Nutrition, Ab
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-0891-2022·2022-04-13

    Abbott ARCHITECT STAT myoglobin calibrators recalled for calibration failure

    Abbott is recalling 402 kits of ARCHITECT STAT myoglobin calibrator that failed stability testing and may produce out-of-specification calibration results. The affected calibrators could impact the accuracy of myoglobin measurements used in clinical diagnostics.

    Product
    ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0924-2022·2022-03-16

    Abbott Similac Advance infant formula recalled for pathogen contamination

    Abbott recalls Similac Advance Step-1 infant formula due to Cronobacter sakazakii and Salmonella Newport detected in the product and manufacturing facility, following consumer complaints in infants.

    Product
    Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per case. Item numbers: 6499213 6698213 Retail UPCs: 055325000808 055325001638
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0937-2022·2022-03-16

    Abbott Similac Sensitive Infant Formula Recalled for Cronobacter and Salmonella Contamination

    Abbott is recalling Similac Sensitive Infant Formula with Iron due to potential Cronobacter sakazakii and Salmonella Newport contamination linked to consumer complaints about infant illness. The FDA classified this as a Class I recall.

    Product
    Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 Retail UPCs: 070074508184
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0940-2022·2022-03-16

    Abbott Similac For Spit Up infant formula recalled for Cronobacter and Salmonella

    Abbott is recalling Similac For Spit Up Infant Formula due to contamination risks. Consumer complaints linked the product to Cronobacter sakazakii and Salmonella Newport, and Cronobacter was found in the manufacturing facility.

    Product
    Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per case. Item numbers: 5095976 Retail UPCs: 070074509600
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0945-2022·2022-03-16

    Abbott Similac Organic Infant Formula Recalled for Bacterial Contamination

    Abbott Similac Organic infant formula products are recalled by the FDA due to potential Cronobacter sakazakii or Salmonella Newport contamination. Consumer complaints of illness in infants and manufacturing facility contamination triggered this Class I recall.

    Product
    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 Retail UPCs: 070074680156 070074680934 0
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0934-2022·2022-03-16

    Abbott Similac Pro-Total Comfort Infant Formula recalled for Cronobacter and Salmonella

    Abbott Similac Pro-Total Comfort Infant Formula is being recalled due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints have been linked to these dangerous pathogens in affected infants.

    Product
    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: 070074667997 070074669403 070074679266 0700
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0922-2022·2022-03-16

    Abbott Similac infant formula recalled for pathogenic bacteria contamination

    Abbott Laboratories is recalling 22,074 cases of Similac for Supplementation infant formula due to potential Cronobacter sakazakii and Salmonella Newport contamination identified through consumer complaints and manufacturing facility testing.

    Product
    Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per case. Item numbers: 63013 Retail UPCs: 070074629506 70074629506
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0941-2022·2022-03-16

    Abbott Similac For Spit Up Infant Formula Recalled for Cronobacter and Salmonella Contamination

    Abbott Similac For Spit Up Infant Formula with Iron is recalled due to consumer complaints of Cronobacter sakazakii and Salmonella Newport, with evidence of Cronobacter sakazakii found in the manufacturing facility.

    Product
    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
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0928-2022·2022-03-16

    Abbott Similac infant formula recalled for possible bacterial contamination

    Abbott is recalling Similac infant formula products for possible contamination with Cronobacter sakazakii and Salmonella Newport following consumer complaints of illness in infants.

    Product
    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
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0956-2022·2022-03-16

    Abbott infant formula recalled for Cronobacter and Salmonella contamination

    Abbott is recalling Similac Alimentum infant formula due to consumer complaints of Cronobacter sakazakii and Salmonella Newport contamination, with evidence of Cronobacter in the manufacturing facility. The recall affects 40,943 cases.

    Product
    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: 070074110431 070074123905 070074110356 070074111
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0932-2022·2022-03-16

    Abbott Similac Pro-Advance Infant Formula Recalled for Bacterial Contamination

    Abbott Similac Pro-Advance infant formula is being recalled due to potential contamination with Cronobacter sakazakii and Salmonella Newport. The FDA Class I recall affects products distributed nationwide and worldwide.

    Product
    Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail UPCs: 055325002567 055325002581
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0958-2022·2022-03-16

    Abbott Similac PM Low Iron Infant Formula Recalled for Bacterial Contamination

    Abbott Similac PM 60/40 Low Iron Infant Formula has been recalled due to contamination with Cronobacter sakazakii and Salmonella Newport. The recall affects 8,358 cases distributed nationally and worldwide.

    Product
    Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans per case. Item numbers: 00850 Retail UPCs: 070074608501
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0951-2022·2022-03-16

    Abbott EleCare Jr Recalled for Bacterial Contamination in Infants

    Abbott is recalling EleCare Jr infant nutrition powder (203,416 cases) due to consumer complaints of Cronobacter sakazakii and Salmonella Newport in infants and contamination found in the manufacturing facility.

    Product
    Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55253 Retail UPCs: 070074552545 70074552545
    Category
    Food
    Distribution
    Distributed nationwide