Unapproved ingredients in FDA food recalls

536 of the 29,386 FDA food recall records published since 2012 name an unapproved ingredient. That is 1.8% of every food recall the agency has reported, and 31 of them are Class I. Data last updated 2 September 2026.

Records of 29,386

536

Share of all recalls

1.8%

Class I of 536

31

Reported between

2012 to 2026

What is different about these records

The hazard that separates Unapproved ingredients from the national picture is chemical contamination: 8.6% of these records name it, against 2.1% of all FDA food recalls.

By product, Unapproved ingredients is weighted toward dietary supplements: 38.1% of the records here against 6.2% across the corpus.

Recalls involving unapproved ingredients skew less severe than the corpus: 5.8% are Class I against 44% nationally.

A recall involving unapproved ingredients stays open a median of 448 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.

A larger share than usual is not voluntary: 32.5% of the records involving unapproved ingredients were requested or mandated rather than begun by the firm, against 1.4% across the corpus.

These recalls travel further than most: 33.6% state nationwide distribution, against 20.7% of all records.

The volume is falling: 44 records in the three years to 2025, against 138 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.

What Unapproved ingredients means in a recall record

An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.

The firm with the most records of this kind is Iowa Select Herbs LLC, with 104. A high count usually reflects one event split across many product codes rather than many separate failures, which is why the table below is ordered by date rather than by firm.

The clause this maps to

A preventive controls plan covers an unapproved ingredient under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 111

Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.

21 CFR 117 subpart G

Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

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.

• Iowa Select Herbs LLC104
• Mira Health Products Ltd.79
• Sundial Herbal Products68
• ProSupps USA LLC18
• Materne North America Corp17
• Hi-Tech Pharmaceuticals Inc.16
• FreshPoint Central Florida15
• Organic By Nature, Inc.14
• San Gennaro Foods, Inc14
• Empirical Laboratories, Incorporated13
• Chicken of the Sea; Thai Union10
• Aroma Meats LLC10

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.

• New York173
• Iowa108
• California58
• Florida30
• New Jersey27
• Texas22
• Georgia18
• Washington14
• Oregon13
• Colorado13
• Tennessee10
• Rhode Island6

Most recently reported

Questions

How many FDA food recalls involve unapproved ingredients?

536 of the 29,386 FDA food recall records published since 2012 name an unapproved ingredient, which is 1.8% of all of them. 31 are Class I, the class the FDA uses when there is a reasonable probability of serious health consequences or death.

What is Unapproved ingredients?

An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.

Which clause covers an unapproved ingredient?

A preventive controls plan under 21 CFR 117 covers an unapproved ingredient under 21 CFR 111, 21 CFR 117 subpart G. Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch. This is where the control belongs; a recall record states a reason rather than a regulatory finding, and most FDA food recalls are initiated by the firm itself.

All FDA food recall data