What brand of melatonin was recalled? Understanding Safety Concerns and Product Alerts

October 13, 2025 •

5 min read

According to a 2023 study published in JAMA, nearly 90% of melatonin gummy brands tested were inaccurately labeled, highlighting significant inconsistencies in the supplement market. While recent public attention has focused on these labeling issues, a number of specific products have been subject to a more serious voluntary or regulatory recall, prompting consumers to ask, "What brand of melatonin was recalled?". This guide details past recalls and highlights broader safety concerns surrounding melatonin supplements.

Quick Summary

Several melatonin products have been recalled or faced public alerts due to contamination, manufacturing deviations, and mislabeling. These include vitafusion gummies for potential metallic mesh, Life Brand tablets for incorrect dosing, and Ultra Seal products for manufacturing issues. Additionally, brands like Olly and Zarbee's have faced lawsuits over inconsistent dosages, underscoring the risks associated with loosely regulated dietary supplements.

Key Points

Vitafusion was recalled for contamination: In 2021, Church & Dwight recalled vitafusion melatonin gummies due to the presence of potential metallic mesh material.
Life Brand was recalled for mislabeling: Health Canada recalled Life Brand Timed Release Melatonin 10mg in 2025 due to incorrect dosage instructions on the label.
Natrol was recalled for mispackaging: In 2021, Natrol, LLC recalled a batch of melatonin that was mislabeled and packaged as ALA capsules instead.
FDA has issued warnings: The FDA has issued warnings and enforcement reports regarding other melatonin product issues, such as those from Ultra Seal Corporation due to manufacturing deviations.
Dosage accuracy is a major concern: Independent testing and lawsuits have repeatedly shown that many melatonin supplements, including gummies, contain significantly different doses than what is listed on the label.
Regulation is limited: As dietary supplements, melatonin products are not subject to the same stringent FDA approval process as drugs, which necessitates greater consumer scrutiny.
Third-party testing is crucial: Consumers can increase confidence in a product's accuracy by choosing brands with third-party verification seals from organizations like USP or NSF.

Why Melatonin Recalls Occur

Unlike prescription medications, dietary supplements like melatonin are not subject to U.S. Food and Drug Administration (FDA) approval for safety and effectiveness before they are sold to the public. This limited regulatory oversight is a primary reason for the wide variance in product quality and the prevalence of recalls and warnings. These recalls can stem from several issues, including manufacturing contamination, mislabeling, and deceptive marketing practices.

Notable Melatonin Product Recalls and Safety Alerts

Vitafusion Gummy Melatonin (2021)

In April 2021, Church & Dwight Co Inc. voluntarily recalled several of its vitafusion gummies, including some melatonin products. The recall was initiated after two consumer reports identified the possible presence of a metallic mesh material in certain product lots. While no injuries were reported, the company acted out of caution, as ingesting such material could potentially damage the digestive tract.

Life Brand Timed Release Melatonin (2025)

In April 2025, Health Canada issued a recall for specific lots of Life Brand Timed Release Melatonin 10mg tablets. This recall was due to incorrect dosing instructions printed on the label, which could lead consumers to take an unintended dose. The affected product was sold at major Canadian retailers, including Shoppers Drug Mart.

Natrol, LLC Melatonin (2021)

In April 2021, Natrol, LLC voluntarily recalled a lot of its 3 mg melatonin tablets. The recall was due to mislabeling, where a lot of melatonin tablets were mistakenly labeled and packaged as ALA (Alpha Lipoic Acid) capsules. The FDA classified this as a Class II recall, indicating the product may cause temporary or medically reversible adverse health consequences.

Kirkland Signature Melatonin (2025)

In July 2025, the Philippine FDA issued a public health warning against the unregistered food supplement "KIRKLAND SIGNATURE Extra Strength Melatonin Dietary Supplement Capsule". The warning was for an unregistered version of the product, indicating potential safety risks due to unverified dosage and content.

Ultra Seal Corporation Melatonin Products (2022)

In early 2022, Ultra Seal Corporation recalled melatonin sleep products, including REMfresh Lite (0.5 mg) and MidNite Sleep Health (1.5 mg), due to deviations from manufacturing practice regulations. The recall was prompted by manufacturing issues that could impact product quality.

Melatonin Supplement Labeling and Dosage Issues

Beyond formal recalls for contamination, a significant concern in the melatonin market is the widespread issue of inconsistent dosage and misleading labeling. This is highlighted by multiple studies and legal actions:

JAMA Study (2023): A laboratory analysis of 25 melatonin gummy brands found that 88% were inaccurately labeled. Some products contained up to 347% more melatonin than advertised, while one contained no melatonin at all, but did contain a significant amount of CBD.
Olly Lawsuit (2022): A class-action lawsuit filed against Olly alleged that its melatonin supplements were "overdosed" based on third-party testing. The suit claimed the supplements contained between 165% and 274% of the advertised melatonin, leading to potential health risks.
Zarbee's Lawsuit (2023): Zarbee's faced a class-action lawsuit alleging its kids' melatonin gummies contained twice the amount of melatonin advertised. The lawsuit underscored the particular dangers of inaccurate dosing for children.
ZzzQuil Lawsuit (2025): Multiple class-action lawsuits were filed against Procter & Gamble, alleging that its ZzzQuil "PURE Zzzs" products were falsely advertised as "natural" when they contained synthetic ingredients.

Comparison of Melatonin Product Issues


Issue Type	Brands Affected	Example Product	Reason for Concern	Date/Status
Contamination	vitafusion (Church & Dwight)	Kids Melatonin Gummies	Possible metallic mesh fragments	Recalled (2021)
Mislabeling (Dosage)	Life Brand (Health Canada)	Timed Release Melatonin 10mg	Incorrect dosing instructions on label	Recalled (2025)
Mislabeling (Contents)	Natrol, LLC	Melatonin 3 mg Tablets	Melatonin tablets mislabeled as ALA capsules	Recalled (2021)
Manufacturing Deviation	Ultra Seal Corp.	REMfresh Lite, MidNite Sleep Health	Failure to meet manufacturing practice regulations	Recalled (2022)
Dosage Inaccuracy	Olly, Zarbee's, others	Various melatonin gummies	Lab tests found significantly different amounts of melatonin than advertised	Lawsuits/Ongoing Issue
"Natural" Marketing	ZzzQuil (Procter & Gamble)	PURE Zzzs series	Lawsuit alleging synthetic ingredients despite "natural" claims	Lawsuits (2025)

How to Choose a Safe Melatonin Supplement

Given the inconsistent regulation of the supplement market, consumers should take proactive steps to ensure the safety and quality of any melatonin product they purchase. Look for supplements that have been verified by a third-party organization.

Check for Third-Party Seals: Seek products tested by independent organizations like U.S. Pharmacopeia (USP), NSF International, or ConsumerLab.com. These certifications indicate that the product has been tested and verified for content, quality, and purity.
Understand Dosing: The optimal melatonin dose can be very low. Start with a small dose (e.g., 0.5 to 3 mg) and consult a healthcare provider, particularly before giving it to children. Inconsistent dosing can lead to potential side effects.
Check for Recalls: Stay informed about current recalls by checking the FDA and Health Canada websites regularly. Be aware that voluntary recalls by manufacturers may not always be widely publicized.
Research the Brand: Look into the manufacturer's reputation and search for any consumer warnings or class-action lawsuits. As seen with brands like Olly and Zarbee's, legal actions can reveal long-term quality control issues.

Conclusion

The answer to "What brand of melatonin was recalled?" is not a single name but a list of several products over time, including vitafusion, Life Brand, and Natrol, LLC. Beyond these formal recalls, the broader issue of inaccurate labeling, as highlighted in the 2023 JAMA study, poses a significant concern for consumers. Because melatonin is largely unregulated as a dietary supplement, consumers must be vigilant and prioritize products with third-party verification to ensure safety and accurate dosing. Always consult a healthcare provider for advice on supplements and dosages.

Third-Party Supplement Testing and Certification Guide

Key Takeaways

Multiple brands recalled: Several melatonin products from brands like vitafusion, Life Brand, and Natrol, LLC have been recalled for safety issues, including metallic mesh contamination and mislabeling.
Widespread mislabeling issue: A 2023 study found nearly 90% of melatonin gummies were inaccurately labeled, with some containing much higher or lower doses than claimed.
Supplements are unregulated: Melatonin is a dietary supplement, meaning it does not have to be approved by the FDA for safety or efficacy before being marketed.
Prioritize third-party verification: To ensure product quality and accurate dosing, choose supplements certified by third-party testing organizations like USP, NSF, or ConsumerLab.com.
Lawsuits highlight risks: Class-action lawsuits against brands like Olly and Zarbee's over dosage inaccuracies and marketing claims reinforce the need for consumer caution.

Frequently Asked Questions

Recent recalls and safety alerts have involved several brands, including vitafusion (due to metallic mesh contamination), Life Brand (due to mislabeled dosing), Natrol, LLC (due to mispackaging), and Ultra Seal Corporation (due to manufacturing deviations).

In 2021, Church & Dwight recalled certain vitafusion gummy products, including melatonin, because of the possible presence of metallic mesh material found during a manufacturing investigation.

Yes, a 2023 study published in JAMA found that nearly 90% of melatonin gummy brands tested were inaccurately labeled, with some containing significantly more or less melatonin than advertised.

The FDA does not approve dietary supplements like melatonin for safety and effectiveness before they are sold. The agency can, however, take action on products found to be unsafe or mislabeled after they are already on the market.

Third-party testing is when an independent organization, such as USP or NSF International, tests a supplement to verify its contents, potency, and purity. Since supplements are unregulated, this certification provides consumers with a valuable layer of quality assurance.

Yes, brands such as Olly and Zarbee's have faced class-action lawsuits over allegations of inaccurate dosing and mislabeling. In some cases, products were found to contain significantly higher doses of melatonin than advertised.

You can check for products that have been verified by third-party organizations like USP. Additionally, you should search for official recall notices from regulatory bodies like the FDA and Health Canada before purchasing.