Dietary supplements in FDA food recalls

1,831 of the 29,386 FDA food recall records published since 2012 involve a dietary supplement, which is 6.2% of every food recall the agency has reported. 407 are Class I, and the median one ran 15 months. Data last updated 2 September 2026.

Records of 29,386

1,831

Share of all recalls

6.2%

Class I of 1,831

407

Reported between

2012 to 2026

What is different about these records

The hazard that separates Dietary supplements from the national picture is unapproved ingredients: 11.1% of these records name it, against 1.8% of all FDA food recalls.

These records overlap heavily with beverages and juice: 12.8% of them also fall under that category, against 5.3% across the corpus. A record can carry more than one category.

Recalls involving a dietary supplement skew less severe than the corpus: 22.2% are Class I against 44% nationally.

A recall involving a dietary supplement 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: 13.7% of the records involving a dietary supplement were requested or mandated rather than begun by the firm, against 1.4% across the corpus.

These recalls travel further than most: 30.6% state nationwide distribution, against 20.7% of all records.

Why dietary supplements recalls the way it does

Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.

Measured across these 1,831 records, undeclared allergens is the most frequent reason at 566, then unapproved ingredients at 204. A record can name more than one hazard, so these overlap and do not sum to 1,831.

What goes wrong

• Undeclared allergens566
• Unapproved ingredients204
• Salmonella147
• Foreign material89
• Chemical contamination59
• Spoilage and mould52
• Listeria monocytogenes19
• E. coli14
• Clostridium botulinum8
• Process deviation4

The regulation that governs it

Dietary supplements are the one category whose manufacturing rule is not part 117: it is 21 CFR part 111, the dietary supplement good manufacturing practices, published in June 2007 and written as 84 questions. The ones this category's records turn on are the specifications a component and a finished batch must meet (§111.70), the testing that shows they are met, including identity testing of dietary ingredients (§111.75), and the master manufacturing record (§111.205). A supplement containing an ingredient that is not a dietary ingredient at all, most often an undeclared drug, is adulterated, which is why that reason dominates here and appears in no other category. Labelling is under part 101, with the supplement facts panel at §101.36.

These are the parts of 21 CFR that bear on a dietary supplement, reproduced in full on this site because title 21 is United States public domain.

• 21 CFR Part 11184Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
• 21 CFR Part 10150Food Labeling

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.

• Sunset Natural Products Inc.166
• Mira Health Products Ltd.80
• NutraCap Labs LLC67
• Health One Pharmaceuticals Inc63
• National Enzyme Co58
• Vitality Works, Inc54
• Sundial Herbal Products46
• Nutrition Resource Services, Inc.36
• Pharmatech LLC33
• TRIANGLE PHARMANATURALS LLC26
• Healthmaxx Global Inc.24
• Giant Eagle23

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.

• California332
• Florida256
• New York216
• Georgia120
• Pennsylvania72
• Missouri71
• Oregon69
• Washington59
• New Mexico58
• Colorado54
• Texas47
• Utah44

Most recently reported

Questions

How many FDA recalls involve a dietary supplement?

1,831 of the 29,386 FDA food recall records published since 2012 involve a dietary supplement, which is 6.2% of all of them. 407 are Class I.

Why does dietary supplements get recalled?

Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.

What is the most common reason for a dietary supplements recall?

Undeclared allergens appears in 566 of the 1,831 records in this category, followed by unapproved ingredients with 204. A single recall can name more than one hazard, so these counts overlap.

How long does a dietary supplements recall take?

The median recall in this category ran 15 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