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-0158-2023·2022-11-23
Similac Infant Formula Recalled Due to Compromised Seal Integrity
Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 15.9 million bottles are affected across the United States and international locations.
Product
Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Category
Food
Distribution
1 state
HighFDA (Food)·F-0156-2023·2022-11-23
Similac 360 infant formula recalled for compromised seal integrity
Abbott Laboratories is recalling Similac 360 Total Care infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The affected product has been widely distributed domestically and internationally.
Product
Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 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-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-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-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-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-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-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-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-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-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-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-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-0950-2022·2022-03-16
Abbott EleCare Junior Vanilla Infant Formula Recalled for Bacterial Contamination
Abbott is recalling EleCare Junior Vanilla infant formula due to possible contamination with Cronobacter sakazakii or Salmonella Newport. The company found evidence of Cronobacter in the manufacturing facility and received consumer complaints.
Product
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
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-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
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