Abbott Similac 360 Infant Formula recalled for Cronobacter and Salmonella
Abbott is recalling Similac 360 Total Care Infant Formula due to consumer complaints of Cronobacter sakazakii and Salmonella Newport in infants, with Cronobacter found in the manufacturing facility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which per the rubric requires a minimum score of 4. The recall involves high-risk pathogens (Cronobacter sakazakii and Salmonella Newport) with documented consumer complaints of illness in infants and evidence of contamination in the manufacturing facility.
Plain-English summary
Abbott Laboratories is recalling Abbott Similac 360 Total Care Infant Formula with Iron due to potential contamination with Cronobacter sakazakii and Salmonella Newport. The recall was initiated following consumer complaints related to these pathogens in infants, and Cronobacter sakazakii was identified in the manufacturing facility where the product was produced.
The affected products include 20.6 oz and 30.3 oz plastic jars and 7 oz cans, with a total of 342,054 cases affected. The products were distributed nationwide in the United States and worldwide.
Cronobacter sakazakii and Salmonella Newport are serious pathogens that pose significant health risks, particularly to infants. This is classified as a Class I recall by the FDA, indicating a serious health hazard.
The recalled product
- Product
- Abbott 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 070074681108
- Manufacturer
- Abbott Laboratories
- Category
- Food — Infant Formula
- Affected units
- 342,054
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Abbott Laboratories under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 41 products in this recall →Related recalls
Same manufacturer · Abbott Laboratories
See all →- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighHematology analyzers recalled because saturation flags may not be applied
FDA (Devices) · 2025-11-19
- HighCELL-DYN Ruby hematology analyzer system expiration date validation
FDA (Devices) · 2025-04-30
- HighCELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect
FDA (Devices) · 2025-04-30
- HighCELL-DYN Ruby hematology analyzer expiration date software defect
FDA (Devices) · 2025-04-30
Same hazard · cronobacter sakazakii
See all →- SevereEnfamil Nutramigen Infant Formula Recalled for Potential Cronobacter Contamination
FDA (Food) · 2024-01-24
- SevereMead Johnson recalls ProSobee infant formula due to contamination risk
FDA (Food) · 2023-03-22
- HighFiber Powder Dietary Supplement Recalled for Cronobacter sakazakii Contamination
FDA (Food) · 2023-02-15
- Severe
- HighKing's Hawaiian Pretzel Buns Recalled for Potential Bacterial Contamination
FDA (Food) · 2022-09-14