10%

Fewer recalls than
Supplements & Specialty peers

Abbott Laboratories — FDA Recall History & Enforcement Records

Established Player · Supplements & Specialty

Data Notice: Recall frequency varies by category and firm size; data is comparative and may not indicate actual brand safety or quality. See Methodology.

As of July 16, 2026, Abbott Laboratories has 61 recorded FDA food enforcement actions in the openFDA database. Their most recent recall was on 31 Oct 2023. Abbott Laboratories is categorized under Supplements & Specialty based on their predominant recall history.

61
Total FDA recalls
11.5
Years in FDA database
5.3
Recalls per year
989 days(2.7 yrs)
Since last recall
67.2%
Class I (life-threatening)
5.3 recalls/yr vs Supplements & Specialty avg 2.3/yrWell Above Average

Recall activity over time for Abbott Laboratories

How serious are Abbott Laboratories recalls?

FDA recall classifications by severity

Class I (Life-threatening)
67.2% (41 recalls)
Class II (Moderate risk)
31.1% (19 recalls)
Class III (Minor violation)
1.6% (1 recalls)

Full FDA recall history for Abbott Laboratories

All 61 FDA enforcement actions sourced from openFDA · Sorted by date, most recent first

Date Product Reason Class & Status
31 Oct 2023Official FDA Notice Similac Probiotic Tri-Blend – 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton – 3 cartons per case. Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive Class IITerminated
28 Mar 2023Official FDA Notice Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton Potential of foreign material (hard plastic) within product Class IITerminated
13 Oct 2022Official FDA Notice Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 c Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 – 4 packs in a case, 48 count case Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 – 6 count carton Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Similac Water – Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case Compromised seal integrity which could lead to spoilage Class IITerminated
13 Oct 2022Official FDA Notice Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count case Compromised seal integrity which could lead to spoilage Class IITerminated
3 Jul 2022Official FDA Notice Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) Potential leaking/pinholes in bottle Class IITerminated
3 Jun 2022Official FDA Notice Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Fl The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declare Class IIITerminated
3 Jun 2022Official FDA Notice Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 Q These products are being recalled due to the potential of leakage from the 1L container. Class IITerminated
3 Jun 2022Official FDA Notice Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ These products are being recalled due to the potential of leakage from the 1L container. Class IITerminated
17 Feb 2022Official FDA Notice Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Alimentum, Abbott Similac Alimentum, Abbott Similac Alimentum HMO, Abbott Alimentum Similac, Abbott Similac Gold Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per case. Item numbers: 63013 Retail UPCs: 070074 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail U Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 R Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case I Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac For Spit Up Infant Formula with Iron 7oz. can and 19.5oz. plastic jar. 6 units per case. Item numbers: Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Organic with A2 Milk Infant Formula with Iron 20.6oz. Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 Re Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive Infant Formula with Iron 12.5oz. Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Alimentum Eye Q Plus 400g. can. Abbott Alimentum Eye Q 400g. can. Abbott Alimentum Eye Q Hypoallergenic 4 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. Abbott Similac Advance 34oz. can. 6 cans per case. Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Pro-Advance 20.6oz., 30.3oz., 34oz., and 658g plastic jar. 6 jars per case. 7oz. can. 6 cans per case. Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 cans per case. 20.1oz. and 29.5oz. plastic Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per case. Item numbers: 6499213 6698213 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar. 4 jars per case. Abbott Similac Organic Toddler w Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per case. Abbott Similac Advance Step-2 34oz. can Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item numbers: 6259962 Retail UPCs: 070074119953 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Alimentum 400g. can. 6 cans per case. Item numbers: 5705806 Retail UPCs: 8699548994869 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UP Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz. can. 6 cans per case. Item numbers: 66273 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palstic jar. 4 jars per case. 7oz. can. 6 can Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 Re Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per case. Item numbers: 5095976 Retail UP Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 07007410459 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Pro-Total Comfort Infant Formula with Iron 20.1oz. and 22.5oz. plastic jar. 4 jars per case. 34oz. plasti Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Alimentum with 2′-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum in Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron 14.1oz. can, Abbott Elecare 400g. can, Abbott Elecare Un Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott EleCare Junior Vanilla 14.1oz. can and Abbott EleCare Jr Similac Vanilla 14.1oz. can. 6 cans per case. Item Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans per case. Item numbers: 5351034 5351 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic jar. 6 jars per case. Item numbers: 6499813 Retail UP Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55253 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Alimentum Toddler Drink 12.1oz. can. 6 cans per case. Item numbers: 68398 Retail UPCs: 07007468 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Organic with A2 Milk Infant Formula with Iron 8oz. and 7oz. can. 6 cans per case. 20.6oz. plastic jar. 4 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Pro-Sensitive Infant Formula with Iron 20.1oz. and 22.5oz. plastic jar. 4 jars per case; 34oz. plastic ja Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Pro-Advance Infant Formula with Iron 20.6oz. and 23.2oz. plastic jar. 4 jars per case; 34oz. plastic jar. Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans per case. Item numbers: 00850 Retail UPCs: Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: Clinical Retail UPCs: N/A – Clinical Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
17 Feb 2022Official FDA Notice Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz. can. 4 cans per case; 7oz. can. 6 Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil Class IOngoing
13 Sep 2019Official FDA Notice Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case. Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container. Class IITerminated
28 Jan 2015Official FDA Notice Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container. The firm received three consumer calls of product with Chinese labeling. After an internal investigation, the firm discovered that product manufactur Class IITerminated

Where have Abbott Laboratories recalls occurred?

States affected across all recorded FDA enforcement actions

Nationwide

Where does this recall data come from?

Verification required: FoodRecallFinder.com cannot verify the safety of individual food products in your possession. Always verify the current recall status at FDA.gov before disposing of or consuming a product.

Data sourced from the FDA Recall Enterprise System via openFDA API. This information is for educational purposes only and does not constitute health or legal advice. FoodRecallFinder.com is not affiliated with or endorsed by the U.S. Food and Drug Administration.

To determine if your specific product is affected, verify that the brand name, product description, lot number, UPC code, and date range all match the recall details exactly. When in doubt contact the recalling firm or visit FDA.gov.

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