U.S. Food and Drug Administration (FDA) Investigation of Lead in Cinnamon Applesauce Pouches (2023)

Table of Contents

1. What the U.S. Food and Drug Administration Did
2. The North Carolina Cases That Started It
3. The Recall and Its Expansion
4. What U.S. Food and Drug Administration Testing Found in 2023
5. Tracing the Lead to Cinnamon From Ecuador
6. Reports of Children With Elevated Blood Lead
7. What the U.S. Food and Drug Administration Told Parents, Caregivers and Retailers
8. Why the U.S. Food and Drug Administration Said It Needed No Lead Limit to Act
9. What the U.S. Food and Drug Administration Says About Lead and Health
10. What the 2023 Investigation Does Not Do
11. Dates and Status as of 18 October 2026
12. How the Investigation Fits Earlier and Later Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the U.S. Food and Drug Administration Did

This action was a safety investigation, not a regulation. The U.S. Food and Drug Administration’s record of it is a single investigation page on fda.gov, updated on 28 October and on 3, 13, 16, 22 and 30 November and 5, 12, 18, 19 and 26 December 2023 (with further updates in 2024). In 2023 the U.S. Food and Drug Administration:

• issued a public health alert on 28 October 2023 telling parents and caregivers not to buy or feed one brand of apple cinnamon fruit puree pouches to toddlers and young children, and updated it on 3 November to add two store brands;
• oversaw a voluntary recall by the firm, expanded on 9 November 2023;
• moved the case to its outbreak team, the Coordinated Outbreak Response & Evaluation (CORE) Network, working with the Centers for Disease Control and Prevention (CDC) and state and local health departments;
• tested pouches and other products, and screened incoming shipments of cinnamon from several countries for lead;
• placed the manufacturer’s apple cinnamon pouches on an import alert (Import Alert 99-42) on 6 November 2023;
• inspected the manufacturer’s plant in Ecuador in December 2023 and tested cinnamon collected there, working with Ecuadorian authorities.

Because none of this was a rule, there is no Federal Register notice or rulemaking docket for it. (The Federal Register is the U.S. government’s daily journal of rules and notices; a docket is the numbered public file that collects a proposal’s documents and comments.) The one Federal Register item the investigation refers to is the separate January 2023 draft guidance on lead in baby foods, described in sections 4 and 12.

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2. The North Carolina Cases That Started It

The 28 October 2023 alert says the U.S. Food and Drug Administration “was recently made aware of a developing investigation” by the North Carolina Department of Health and Human Services and the North Carolina Department of Agriculture & Consumer Services into “four children with elevated blood lead levels, indicating potential acute lead toxicity.” The state health department’s investigation identified the apple cinnamon fruit puree pouches as “a potential shared source of exposure,” and its analysis of multiple lots detected “extremely high concentrations of lead.”

The U.S. Food and Drug Administration wrote that it “has reviewed and supports” the state’s analytical findings and “found that analytical results at this level could result in acute toxicity.” It shared the results with the firm, whose representatives were cooperating and agreed to recall all of the brand’s apple cinnamon fruit puree pouches regardless of expiration date.

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3. The Recall and Its Expansion

A voluntary recall is one a company carries out itself, here under U.S. Food and Drug Administration oversight. The U.S. Food and Drug Administration’s timeline of the early investigation, posted in December 2023, records these steps:

• 28 October 2023: the U.S. Food and Drug Administration discussed the findings with the firm and issued its safety alert; the firm agreed the same day to recall the product. The recall itself got under way at the end of October 2023, when the firm notified its customers and issued a press release.
• 2 November: after reviewing records the firm provided for the recall, the U.S. Food and Drug Administration learned that two store brands of cinnamon applesauce pouches made by the same Ecuadorian manufacturer were also implicated and needed public notice.
• 3 November: the U.S. Food and Drug Administration updated its alert to include the two store brands.
• 5 November: on a call with the firm, U.S. Food and Drug Administration staff asked it to update its recall press release and clarify the scope of the recall of all its apple cinnamon fruit puree products; the firm agreed.
• 6 November: the manufacturer’s apple cinnamon fruit puree products were added to Import Alert 99-42. The U.S. Food and Drug Administration describes Import Alert 99-42 as “detention without physical examination of foods due to heavy metal (toxic element) contamination.”
• 9 November: the firm expanded its recall announcement to cover the two store brands. Customer records showed product had also gone to Cuba and the United Arab Emirates.

On 22 November the U.S. Food and Drug Administration reported that the recalled pouches were still on the shelves of a national discount retailer’s stores in several states, and said it was “working with the firm to ensure an effective recall.” The U.S. Food and Drug Administration’s enforcement steps on that point came in 2024 and are reported on the 2024 ground-cinnamon page.

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4. What U.S. Food and Drug Administration Testing Found in 2023

• The pouches. On 16 November 2023 the U.S. Food and Drug Administration reported that one finished pouch it sampled from a discount retailer contained 2.18 ppm of lead. The agency put this in context as “more than 200 times greater than the action level of 0.01 ppm that the U.S. Food and Drug Administration has proposed in draft guidance for fruit purees and similar products intended for babies and young children.” (0.01 ppm is the same as 10 parts per billion.)
• Other pouches from the same brands. The same update said samples of the brands’ fruit puree pouches that do not contain cinnamon and were not recalled had not shown elevated lead.
• The cinnamon. On 18 December the U.S. Food and Drug Administration reported that cinnamon its investigators collected at the Ecuadorian plant showed “extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm.” For context it noted that the Codex Alimentarius Commission, the international food-standards body, was considering a maximum of 2.5 ppm for lead in bark spices, including cinnamon, in 2024. On 26 December the U.S. Food and Drug Administration added that 5,110 ppm was “more than 2,000 times” that level.
• Everything else tested. By 18 December the U.S. Food and Drug Administration and state partners had tested at least 136 samples of products without cinnamon, all negative for elevated lead, and the U.S. Food and Drug Administration said no further products were being added to the recall.
• Cinnamon at the border. From mid-November the U.S. Food and Drug Administration screened incoming shipments of cinnamon from multiple countries for lead; as of 30 November it reported no screening results positive for higher levels of lead.

An action level is a figure the U.S. Food and Drug Administration uses to decide when a food may be considered unsafe. The 0.01 ppm action level quoted in 2023 came from draft guidance published in January 2023 and was not final at the time; the U.S. Food and Drug Administration later finalized that guidance (section 12).

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5. Tracing the Lead to Cinnamon From Ecuador

By 16 November 2023 the U.S. Food and Drug Administration’s “leading hypothesis” was that the cinnamon in the recalled pouches was the likely source, though it had not yet been able to test that cinnamon. On 30 November the manufacturer and its U.S. distributor released a statement that their own root cause investigation pointed to the cinnamon, which had come from a third-party distribution company in Ecuador.

The December updates describe the rest of the 2023 trail:

• Ecuador’s regulator. On 5 December the U.S. Food and Drug Administration reported that Ecuadorian authorities had found the cinnamon supplier’s cinnamon had higher levels of lead than Ecuador allows, and that the supplier was under an Ecuadorian administrative sanctions process to determine responsibility. The U.S. Food and Drug Administration names the regulator as the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA).
• The plant inspection. The U.S. Food and Drug Administration began an onsite inspection of the manufacturer’s plant in Ecuador by 5 December and reported on 18 December that it had ended; investigators collected the cinnamon samples described in section 4.
• Where the cinnamon went. The U.S. Food and Drug Administration confirmed that the cinnamon supplier does not ship product directly to the U.S. and that, of its direct customers, only the pouch manufacturer ships product to the U.S. ARCSA reported that the supplier does not ship outside Ecuador, that raw cinnamon from cinnamon importers in Ecuador did not appear to be contaminated in its testing so far, whereas the supplier’s ground or powdered cinnamon was, and that the processor the supplier used was not operating.
• The limits of U.S. Food and Drug Administration authority. The U.S. Food and Drug Administration wrote that it “has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing prior to export.” It said it could not take direct action against the supplier and was relying on Ecuadorian officials.
• Other countries. The U.S. Food and Drug Administration said it was sending updates of its advisory to other countries through the World Health Organization’s International Food Safety Authority Network (INFOSAN), which includes more than 200 partner countries.

The 2023 updates do not say how or why the lead got into the cinnamon. The U.S. Food and Drug Administration’s later findings on that question date from 2024 and are reported on the 2024 page.

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6. Reports of Children With Elevated Blood Lead

The U.S. Food and Drug Administration counted complaints and adverse event reports sent to it that were potentially linked to the recalled pouches. Its counts rose through the autumn:

• 22 reports by 13 November 2023;
• 34 by 16 November;
• 52 by 22 November (confirmed complainants aged under 1 to 4 years);
• 57 by 30 November (aged under 1 to 5 years);
• 64 by 5 December;
• 65 by 11 December;
• 69 by 19 December, with all confirmed complainants under 6 years of age;
• 82 confirmed reports by 26 December, when the U.S. Food and Drug Administration gave the complainants’ ages as between zero and 53 years.

On 5 December the U.S. Food and Drug Administration explained that it was counting reports that noted a blood lead level at or above 3.5 micrograms of lead per deciliter of whole blood (µg/dL) within 3 months after eating a recalled product. It described 3.5 µg/dL as the U.S. Centers for Disease Control and Prevention’s blood reference level, “the level at which the U.S. Centers for Disease Control and Prevention recommends clinical monitoring of lead exposure in children.” U.S. Centers for Disease Control and Prevention’s case definition for state health departments, as the U.S. Food and Drug Administration reported it, was a blood lead level of 3.5 µg/dL or higher measured within 3 months after eating a recalled product after November 2022.

The U.S. Food and Drug Administration cautioned on how to read these numbers. It relies on self-reported information from health care providers, consumers and some states, and wrote that, unlike germ outbreaks that can be linked genetically, “lead exposure in an individual can result from several sources. There is no established method to link lead exposure in an individual to a specific source.” U.S. Centers for Disease Control and Prevention kept its own case count through state health departments; the U.S. Food and Drug Administration said the two agencies’ counts come from different data sources and “should not be added together.” Only the U.S. Food and Drug Administration’s figures are given here.

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7. What the U.S. Food and Drug Administration Told Parents, Caregivers and Retailers

The 28 October alert advised “parents and caregivers not to purchase or feed” the recalled pouches “to toddlers and young children because they may contain elevated levels of lead.” The investigation page, in its current form, says the recalled products are off the market but have a long shelf life, and states that consumers should not eat, sell or serve them and should discard them. It describes a way to throw them out: opening the pouch and emptying the contents into a trash can before discarding the packaging, so that others cannot salvage recalled product, then cleaning up spills and washing hands. The 22 November update gave the same disposal steps to retailers.

The U.S. Food and Drug Administration also noted that most children have no obvious immediate symptoms of lead exposure, and stated that when a child may have been exposed, parents should talk to the child’s health care provider about a blood test. For clinicians it pointed to U.S. Centers for Disease Control and Prevention’s Health Alert Network advisory. These are the U.S. Food and Drug Administration’s statements; decisions about testing or care for a particular child belong with that child’s clinician.

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8. Why the U.S. Food and Drug Administration Said It Needed No Lead Limit to Act

On 26 December 2023, after comparing its results with the proposed 0.01 ppm action level and the 2.5 ppm level under Codex consideration, the U.S. Food and Drug Administration wrote: “Although there are proposed action levels for lead used for comparison, it is important to underscore that the U.S. Food and Drug Administration does not need an action level or guidance to take action when food contains a harmful substance, such as lead, that may render the food injurious to health.”

The 16 November update reminded industry of its legal duties. It stated that companies distributing food sold in the U.S. are legally responsible for complying with the Federal Food, Drug, and Cosmetic Act and U.S. Food and Drug Administration regulations, and that “by law, food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed,” including putting in place any controls needed to reduce or eliminate lead in their products. It explained that most food manufacturers are covered by the preventive control provisions of the U.S. Food and Drug Administration’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, which require controls for identified chemical hazards such as lead, and that some manufacturers also test their finished products.

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9. What the U.S. Food and Drug Administration Says About Lead and Health

The investigation page states that lead “is toxic to humans and can affect people of any age or health status,” and that protecting children is particularly important “because they are more susceptible to lead toxicity.” It lists the symptoms the U.S. Food and Drug Administration associates with lead:

• Short-term exposure: headache, abdominal pain or colic, vomiting and anemia.
• Longer-term exposure could add irritability, lethargy, fatigue, muscle aches or muscle prickling or burning, constipation, difficulty concentrating or muscular weakness, tremor and weight loss.

The page repeats that most children show no obvious immediate symptoms, which is why the U.S. Food and Drug Administration points to a blood test rather than symptoms. More on lead and the body is on the site’s lead page.

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10. What the 2023 Investigation Does Not Do

• It sets no legal lead limit. The 0.01 ppm figure the U.S. Food and Drug Administration quoted was a proposed action level in draft guidance, used for comparison; the 2.5 ppm figure for bark spices was a level under consideration by Codex.
• The recall was voluntary. It was carried out by the firm under U.S. Food and Drug Administration oversight, not ordered by the U.S. Food and Drug Administration.
• It does not cover other cinnamon products. The U.S. Food and Drug Administration reported no indication in 2023 that the problem extended beyond the recalled pouches, and no further products were added to the recall. The U.S. Food and Drug Administration’s separate 2024 alerts on ground cinnamon are a later action.
• It does not assign intent. The 2023 updates traced the lead to the supplier’s ground cinnamon but did not say how or why it got there.
• It does not merge U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention counts. The U.S. Food and Drug Administration reported its own complaint counts and said they are not to be added to U.S. Centers for Disease Control and Prevention’s.

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11. Dates and Status as of 18 October 2026

• 25 January 2023: U.S. Food and Drug Administration draft guidance proposing lead action levels for foods for babies and young children (88 FR 4797); comment period reopened to 8 May 2023 (88 FR 20525, 6 April 2023).
• 28 October 2023: U.S. Food and Drug Administration public health alert; the firm agrees to a voluntary recall, which begins at the end of October.
• 3 November: alert updated to add two store brands.
• 6 November: the manufacturer’s apple cinnamon pouches added to Import Alert 99-42.
• 9 November: expanded recall announcement.
• 16 November: U.S. Food and Drug Administration reports 2.18 ppm lead in a recalled pouch.
• 22 November: U.S. Food and Drug Administration reports recalled pouches still on some discount-store shelves.
• 5–18 December: U.S. Food and Drug Administration inspection of the Ecuadorian plant.
• 18 December: cinnamon from the plant measures 5,110 and 2,270 ppm lead; no further products added to the recall.
• 26 December: U.S. Food and Drug Administration states it needs no action level to act against food made harmful by lead.

Status as of 18 October 2026: the U.S. Food and Drug Administration’s investigation page now lists the investigation’s status as “Ended” and says the U.S. Food and Drug Administration’s response “has transitioned from this investigation to post-incident actions and activities.” The investigation was not a rule, so there is nothing to finalize, stay or withdraw. A check of the Federal Register through 18 October 2026 found no document that changes its status. The draft lead guidance it cited was finalized on 7 January 2025 (90 FR 1135), with a correction on 21 April 2025 (90 FR 16692).

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12. How the Investigation Fits Earlier and Later Actions

The investigation came nine months after the U.S. Food and Drug Administration proposed its first lead action levels for processed foods for babies and young children. The January 2023 draft (Docket No. FDA-2022-D-0278) would set 10 parts per billion for fruits, vegetables other than single-ingredient root vegetables, mixtures, yogurts, custards and puddings, and single-ingredient meats; and 20 parts per billion for single-ingredient root vegetables and for dry cereals. That 10 ppb figure is the 0.01 ppm level the U.S. Food and Drug Administration used for comparison in November and December 2023. The final guidance, issued in January 2025, sets action levels for certain processed foods for children under 2 years old; its story is told on the site’s page on U.S. Food and Drug Administration action levels for lead in baby food (2025).

The applesauce investigation continued into 2024: further laboratory findings, import alerts on the cinnamon supplier, warning letters, and the U.S. Food and Drug Administration’s March 2024 alerts on ground cinnamon sold in the U.S. Those later steps are reported on the page on U.S. Food and Drug Administration lead alerts on ground cinnamon (2024) and are not repeated here.

Other 2023 U.S. Food and Drug Administration actions on foods for babies and children include the steps to tighten infant formula safety and the warning on probiotics for preterm infants. Contamination of spices and supplements with heavy metals more broadly is covered on the site’s contamination page.

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13. Primary Documents

1. U.S. Food and Drug Administration. Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches (November 2023). Outbreak investigation page with dated updates from 28 October 2023 (2023 updates: 28 October; 3, 13, 16, 22, 30 November; 5, 12, 18, 19, 26 December); content current as of 3 October 2024 — fda.gov investigation page
2. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2023). Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability. Federal Register 88:4797, 25 January 2023. Docket No. FDA-2022-D-0278 — FR Doc. 2023-01384
3. Food and Drug Administration, U.S. Department of Health and Human Services (2023). Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Reopening of the Comment Period. Federal Register 88:20525, 6 April 2023. Docket No. FDA-2022-D-0278 — FR Doc. 2023-07187
4. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability. Federal Register 90:1135, 7 January 2025. Docket No. FDA-2022-D-0278 — FR Doc. 2024-31534; correction, 90 FR 16692, 21 April 2025 — FR Doc. 2025-06786

The U.S. Food and Drug Administration’s original 28 October 2023 safety alert and the firms’ recall announcements are posted on fda.gov under the brand names and are not linked here; the alert’s text appears as the 28 October 2023 entry of the investigation page above.

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Key Research Papers

1. Troeschel AN, Buser MC, Winquist A, Ruckart P, Yeh M, Kuai D, Chang A, Pennington AF, Rumph JT, Smith MR, Lara MV, Cataldo N, Lewis K, Arnold K, Harris S, Nicholas DC, Hughes M, Wortmann T, Norman E, Napier MD, Dillard J, Daniel J (2025). Investigation of lead and chromium exposure after consumption of contaminated cinnamon-containing applesauce - United States, November 2023-April 2024. MMWR Morbidity and Mortality Weekly Report 74(14):239-244 — PubMed PMID: 40273027
2. Cataldo N, Weed BD, Lewis K, Kirchner M, Arnold K, Michael L, Chang A, Daniel JH, Shone S, Yeung L, Mangia J, Troeschel A, Morales J, Kubachka KM, Witkowski M, Schaufler L, Abt E, Pauley S, Ruckart P, Yeh M, Williams TL, Gray P, Hurt D, Salter M, Howard M, Harris S (2026). International investigation of lead and chromium contamination in imported apple puree. Journal of Environmental Health 89(1):20-27 — PubMed PMID: 42516822
3. Hore P, Alex-Oni K, Sedlar S, Nagin D (2019). A spoonful of lead: a 10-year look at spices as a potential source of lead exposure. Journal of Public Health Management and Practice 25(Suppl 1):S63-S70 — PubMed PMID: 30507772
4. Forsyth JE, Nurunnahar S, Islam SS, Baker M, Yeasmin D, Islam MS, Rahman M, Fendorf S, Ardoin NM, Winch PJ, Luby SP (2019). Turmeric means “yellow” in Bengali: lead chromate pigments added to turmeric threaten public health across Bangladesh. Environmental Research 179(Pt A):108722 — PubMed PMID: 31550596
5. Forsyth JE, Mistree D, Nash E, Angrish M, Luby SP (2024). Evidence of turmeric adulteration with lead chromate across South Asia. Science of the Total Environment 949:175003 — PubMed PMID: 39053552
6. Porterfield K, Hore P, Whittaker SG, Fellows KM, Mohllajee A, Azimi-Gaylon S, Watson B, Grant I, Fuller R (2024). A snapshot of lead in consumer products across four US jurisdictions. Environmental Health Perspectives 132(7):75002 — PubMed PMID: 39012763
7. Lanphear BP, Hornung R, Khoury J, Yolton K, Baghurst P, Bellinger DC, Canfield RL, Dietrich KN, Bornschein R, Greene T, Rothenberg SJ, Needleman HL, Schnaas L, Wasserman G, Graziano J, Roberts R (2005). Low-level environmental lead exposure and children’s intellectual function: an international pooled analysis. Environmental Health Perspectives 113(7):894-899 — PubMed PMID: 16002379

The first two papers are public health investigations of this incident by the agencies involved, covering the U.S. exposure investigation and the international tracing of the contaminated puree. The next three look at spices as a source of lead, including adulteration of spices with lead chromate pigment. The sixth reports lead measured in consumer products in four U.S. jurisdictions, and the last is a pooled analysis of low-level lead exposure and children’s intellectual function.

PubMed Topic Searches

1. PubMed: lead contamination of cinnamon
2. PubMed: spices and lead exposure in children
3. PubMed: lead chromate food adulteration

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Connections

• U.S. Food and Drug Administration Actions of 2023
• U.S. Food and Drug Administration and Regulation
• U.S. Food and Drug Administration Lead Alerts on Ground Cinnamon (2024)
• U.S. Food and Drug Administration Action Levels for Lead in Baby Food (2025)
• Lead
• Heavy Metals
• Hexavalent Chromium
• Cinnamon
• Contamination: Heavy Metals, Bacteria and Substitution
• Infant Formula Safety Steps (2023)
• Probiotics for Preterm Infants Warning (2023)
• Cantaloupe Salmonella Outbreak (2023)
• Brominated Vegetable Oil Proposal (2023)

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