Infant formula and baby food in FDA food recalls

95 of the 29,386 FDA food recall records published since 2012 involve infant formula or baby food, which is 0.3% of every food recall the agency has reported. 43 are Class I, and the median one ran 10 months. Data last updated 2 September 2026.

Records of 29,386

95

Share of all recalls

0.3%

Class I of 95

43

Reported between

2012 to 2026

What is different about these records

The hazard that separates Infant formula and baby food from the national picture is salmonella: 25.3% of these records name it, against 12.4% of all FDA food recalls.

These records overlap heavily with milk and dairy: 43.2% of them also fall under that category, against 16.9% across the corpus. A record can carry more than one category.

A recall involving infant formula or baby food stays open a median of 293 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: 55.8% state nationwide distribution, against 20.7% of all records.

The volume is falling: 16 records in the three years to 2025, against 49 in the four before them. 2026 is excluded because the agency reports an enforcement action months after a firm begins a recall, so the most recent year is always incomplete.

Why infant formula and baby food recalls the way it does

Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.

Measured across these 95 records, salmonella is the most frequent reason at 24, then spoilage and mould at 5. A record can name more than one hazard, so these overlap and do not sum to 95.

What goes wrong

• Salmonella24
• Spoilage and mould5
• Foreign material3
• Chemical contamination2
• Clostridium botulinum2
• Undeclared allergens1
• Unapproved ingredients1

The regulation that governs it

Infant formula is the one food with a manufacturing and quality control regulation of its own, 21 CFR part 106, on top of the labelling and nutrient requirements of part 107. Part 106 requires a production and in-process control system (§106.6) and controls against adulteration by workers, facilities, equipment and automated systems (§§106.10 to 106.35), and it is the regulation under which a nutrient outside its specification is an adulteration rather than a quality defect. Part 107 sets the nutrient information (§107.10) and directions for use (§107.20) a label must carry and the exemptions (§107.30). A manufacturer of baby food other than formula is under part 117 like any other processor.

These are the parts of 21 CFR that bear on infant formula or baby food, reproduced in full on this site because title 21 is United States public domain.

• 21 CFR Part 10627Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications
• 21 CFR Part 10716Infant Formula
• 21 CFR Part 11761Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

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.

Firms with the most records

A firm appears here because it reported recalls, which is what a working recall procedure produces. A high count frequently reflects a single event split across many product codes rather than many separate failures.

• Abbott Laboratories25
• Plum Inc19
• Able Groupe Inc17
• PBM Nutritionals, LLC3
• Dairy Manufacturers, Inc3
• Nurture Inc. dba Happy Family3
• 3CS ORGANICS LLC2
• Valley Springs Artesian Gold, LLC1
• Publix Super Markets, Inc.1
• Nutricia North America1
• SunOpta Grains and Foods Inc.1
• PUREFRUIT CHILE S.A1

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.

• California24
• Illinois24
• Nevada17
• New York6
• Vermont3
• Texas3
• Minnesota2
• Michigan2
• Ohio2
• South Carolina2
• Colorado1
• Wisconsin1

Most recently reported

Questions

How many FDA recalls involve infant formula or baby food?

95 of the 29,386 FDA food recall records published since 2012 involve infant formula or baby food, which is 0.3% of all of them. 43 are Class I.

Why does infant formula and baby food get recalled?

Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.

What is the most common reason for a infant formula and baby food recall?

Salmonella appears in 24 of the 95 records in this category, followed by spoilage and mould with 5. A single recall can name more than one hazard, so these counts overlap.

How long does a infant formula and baby food recall take?

The median recall in this category ran 10 months from the date the firm initiated it to the date the FDA terminated it. Termination means the agency judged that all reasonable effort had been made under 21 CFR 7.55; it does not mean no product remained in circulation.

All FDA food recall data