Recalls in the Beauty Industry: Are Your Products Safe? Commentary from recent dermatology study
By Shogo Wada and David G. Li, MD, MBA
Shogo Wada is a physician from Tokyo who is currently a MPH candidate at the Harvard Chan School of Public Health
David Li is a board-certified dermatologist in private practice in downtown Boston and the Founder of BDA. Previously he was a resident at the Harvard Medical School Combined Dermatology Program.
In this series, we explore the intersection of historical beauty practices and modern cosmetic safety, highlighting recently published data in JAAD on product recalls. By examining centuries-old beauty rituals—from ancient Egyptian eyeliner to Queen Elizabeth I’s lead-based face powders—we provide context for today’s cosmetic industry regulations and safety concerns. This piece connects historical beauty trends with modern data to reveal how cosmetic safety has evolved—and where risks still remain.
What is the history of health concerns associated with cosmetic and personal care products?
Any time you use a cosmetic or personal care product, there may be a small, yet not insignificant risk associated with this action. While these risks are likely less considerable than in the distant past, they may still be worth considering, as substantiated by history.
Take lead, for example—a toxic substance now recognized as a serious health hazard, capable of causing skin damage, hair loss, and even neurological disorders. Yet, for centuries, lead was a staple in cosmetics. As early as 3,000 BC, the Egyptians—royalty and commoners alike—painted their eyes with striking black and green powders, much like today’s smoky-eye look. Beyond aesthetics, our ancient ancestors believed this makeup protected against eye infections. What they didn’t know was that the primary ingredient was lead.
This wasn't just an ancient practice. Lead-based pigments, such as white lead and black lead, were widely used across civilizations. Perhaps one of the most famous victims of lead poisoning was Queen Elizabeth I of England. The iconic pale-faced look she is remembered for was not just a beauty statement—it was a desperate attempt to conceal scars left by smallpox.
In 1562, four years after ascending the throne, the 29-year-old queen was struck by smallpox, leaving her face marred with blemishes. Self-conscious and determined to maintain her image, Elizabeth turned to Venetian Ceruse, a highly prized skin-whitening cosmetic popular among European aristocracy. The problem? It was made with white lead.
Elizabeth I became an obsessive user, applying thick layers of Venetian Ceruse to mask her scars, unknowingly exposing herself to chronic lead poisoning. Symptoms such as skin deterioration, hair loss, and neurological damage became evident over time. To make matters worse, the bright red lipstick she favored contained mercury, a toxin known to cause depression, memory loss, and cognitive decline.
Rather than addressing the damage, Elizabeth responded by applying even more makeup, creating a vicious cycle. Her devotion to cosmetics became so extreme that she reportedly left her makeup on for days at a time, allowing toxic metals to leach into her skin. As her hair thinned, she resorted to wearing wigs dyed red with mercury, further exacerbating her condition. Historians speculate that this prolonged exposure contributed to her declining mental health, possibly leading to depression, dementia, and premature aging.
Thanks to modern medicine and regulatory oversight, the dangers of toxic cosmetic ingredients—such as lead and mercury—are now well documented. While lead-based cosmetics were once widely used, we now understand their risks, and regulations prohibit their inclusion in modern beauty products.
In the U.S., the Federal Food, Drug, and Cosmetic Act (FFDCA) was enacted in 1938, granting the Food and Drug Administration (FDA) the authority to regulate cosmetics.(1) However, for decades, the FDA had limited power, unable to mandate adverse event reporting or force product recalls. This changed with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expanded the FDA's oversight.(2)
Under MoCRA, the FDA can now:
Require mandatory reporting of safety issues
Access safety records from companies
Mandate product recalls when necessary
How does the recall system work and why should you, as a consumer of skincare products, care?
Think of a cosmetic recall like a safety alert for a defective smartphone. Imagine you buy the latest phone model, only to find out months later that the batteries are overheating. You'd expect the manufacturer to warn you, right?
Cosmetic recalls function in much the same way. When a company discovers a potential safety issue—such as bacterial contamination or undisclosed ingredients—it first investigates the problem. Then, much like tech companies issuing safety notices, cosmetic brands inform customers via emails, social media, and store announcements. If you've purchased a face cream or shampoo linked to a recall, you'll be advised to stop using it immediately and may be offered a refund.
However, unlike electronics manufacturers, which are legally required to recall faulty products, cosmetic companies often do so voluntarily—not necessarily because the FDA forces them to, but to protect their reputation and consumers.(3)
Understanding the recall system is crucial because cosmetic products can pose hidden health risks. Unlike food recalls, where contaminated products are consumed directly, cosmetics are often layered, making it harder for users to pinpoint the exact cause of a reaction. Skin irritation, infections, or even systemic health effects may not be immediately obvious. If you experience irritation or health issues after using a cosmetic product, report it to the FDA or manufacturer and stay updated on product safety announcements to protect yourself and others.
How many cosmetic product recalls have occurred?
A cross-sectional study by Venkatesh et al. analyzed FDA Enforcement Report data for cosmetic recalls from 2011 to 2023.(4) The findings revealed:
334 total cosmetic product recalls over 13 years
Makeup was the most frequently recalled category (93 cases, 27.9%)
Other major recall categories included:
Soaps, shampoos, and gels (22.8%)
Lotions and conditioners (9.9%)
Recalls fall into three FDA classifications based on risk level:
Class I: Serious health risks, including potential death (1.5% of recalls)
Class II: Temporary or medically reversible health effects (88.9% of recalls)
Class III: Violations of FDA regulations, unlikely to cause health issues (8.68% of recalls)
A particularly concerning case occurred in 2019, when Johnson & Johnson recalled 33,000 bottles of baby powder after the FDA detected trace amounts of asbestos in a sample. Asbestos is a known carcinogen—particularly dangerous when inhaled—raising alarms since baby powder is often used on infants, a vulnerable population. (5)
What are the main reasons for these recalls?
In the study by Venkatesh et al., most recalls were due to microbial contamination, accounting for 255 (76.8%) of the total recalls.
Alarmingly, 80% of Class I recalls—the most severe category indicating serious health risks—were due to microbial contamination.
The primary bacterial culprits included:
Pseudomonas species – detected in 84 cases (54.9%)
Burkholderia species – found in 38 cases (24.8%)
These bacteria are particularly concerning because they can cause a range of infections, from mild ear infections to severe pneumonia and bloodstream infections, especially in individuals with weakened immune systems.(6,7)
In a real world example, one of the most serious Class I recalls involved Burkholderia cepacia contamination in mouthwash—a product ironically designed to prevent infections.(8–10) In the Intensive Care Units (ICUs), critically ill patients—many of whom are on ventilators due to breathing difficulties—often rely on antiseptic mouthwash as part of their care routine. However, in multiple hospitals, Burkholderia cepacia contamination in mouthwash led to pneumonia outbreaks, and tragically, some patients died as a result.
Upon investigation, the bacterial contamination was traced back to the manufacturing process of a specific company's mouthwash. Following rigorous FDA inspections, the product was ultimately recalled preventing further harm.
Other reasons for recalls reported in the present study included fungal contamination (20 [7.8%]), inorganic contamination including asbestos and metals (34 [10.2%]), incorrect or undisclosed ingredients (22 [6.6%]), labeling or packaging errors (16 [4.8%]), and manufacturing or storage issues (3 [0.9%]).
What does this mean for consumers of cosmetic products?
Cosmetic recalls are not just about minor inconveniences—they highlight real health risks, from skin infections to exposure to carcinogens. The high percentage of bacterial contamination in beauty products is particularly concerning, as many of these pathogens can in theory result in infections in vulnerable individuals.
While modern regulations have made cosmetics significantly safer than in the past, recalls remain common, and the beauty industry still operates with regulatory gaps. Unlike the food and pharmaceutical industries, where pre-market safety approval is required, cosmetic companies are largely self-regulated and recalls often occur only after products have been sold to thousands—or even millions—of consumers.
As a consumer, consider the following:
Stay informed about product recalls by checking the FDA website or manufacturer alerts.
Be cautious of brands with frequent recall histories—prioritize reputable, transparent companies.
If you experience skin irritation or other symptoms, report it to the FDA and discontinue use.
Advocate for stronger regulations in the beauty industry to prevent contamination issues before they reach consumers.
The history of cosmetics—from Queen Elizabeth I’s lead-laced beauty routine to modern contaminated skincare products—suggests that beauty should never come at the cost of health. Staying informed is the best way to protect yourself from potential risks.
References
1. Commissioner O. Part IV: Regulating Cosmetics, Devices, and Veterinary Medicine After 1938. FDA. Published online March 15, 2019. Accessed January 19, 2025. https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-iv-regulating-cosmetics-devices-and-veterinary-medicine-after-1938
2. The Modernization of Cosmetics Regulation Act of 2022: What dermatologists need to know - Journal of the American Academy of Dermatology. Accessed January 19, 2025. https://www.jaad.org/article/S0190-9622(23)00721-1/abstract
3. Commissioner O of the. FDA Recall Policy for Cosmetics. FDA. Published online September 27, 2024. Accessed January 19, 2025. https://www.fda.gov/cosmetics/cosmetics-compliance-enforcement/fda-recall-policy-cosmetics
4. Venkatesh KP, Kadakia KT, Akbarpour A, Nambudiri VE. US Food and Drug Administration recalls of cosmetic and personal products from 2011 to 2023: A cross-sectional study. J Am Acad Dermatol. 2025;92(1):179-181. doi:10.1016/j.jaad.2024.09.040
5. Nutrition C for FS and A. Johnson & Johnson Consumer Inc. to Voluntarily Recall a Single Lot of Johnson’s Baby Powder in the United States. May 13, 2021. Accessed January 19, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/johnson-johnson-consumer-inc-voluntarily-recall-single-lot-johnsons-baby-powder-united-states
6. David J, Bell RE, Clark GC. Mechanisms of Disease: Host-Pathogen Interactions between Burkholderia Species and Lung Epithelial Cells. Front Cell Infect Microbiol. 2015;5:80. doi:10.3389/fcimb.2015.00080
7. Goldberg JB. Pseudomonas: global bacteria. Trends Microbiol. 2000;8(2):55-57. doi:10.1016/s0966-842x(99)01671-6
8. Kutty PK, Moody B, Gullion JS, et al. Multistate Outbreak of Burkholderia cenocepacia Colonization and Infection Associated With the Use of Intrinsically Contaminated Alcohol-Free Mouthwash. Chest. 2007;132(6):1825-1831. doi:10.1378/chest.07-1545
9. Zurita J, Mejia L, Zapata S, et al. Healthcare-associated respiratory tract infection and colonization in an intensive care unit caused by Burkholderia cepacia isolated in mouthwash. Int J Infect Dis. 2014;29:96-99. doi:10.1016/j.ijid.2014.07.016
10. Janetos TM, Akintilo L, Xu S. Overview of high-risk Food and Drug Administration recalls for cosmetics and personal care products from 2002 to 2016. Journal of Cosmetic Dermatology. 2019;18(5):1361-1365. doi:10.1111/jocd.12824
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FAQ Section
1. What is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)?
MoCRA expands the FDA's authority over cosmetics, allowing mandatory recalls, safety reporting, and access to company safety records to enhance consumer protection.2. Why do cosmetic recalls happen?
Most recalls are due to bacterial contamination, asbestos, incorrect labeling, or undisclosed ingredients, posing risks like skin infections and long-term health effects.3. How can I check if my skincare products are recalled?
Stay updated by checking the FDA recall database, company announcements, and independent consumer safety sites.4. Are cosmetics regulated as strictly as food and drugs?
No, unlike pharmaceuticals, cosmetics do not require pre-market FDA approval, making recalls the primary safety measure.5. How do I report a reaction to a cosmetic product?
You can report adverse reactions to the FDA via MedWatch or directly to the product manufacturer. -
We are a group of dermatology residents and attending physicians based in Boston, MA. Our team of Ivy League-trained dermatologists is demystifying the cosmeceutical industry by offering unbiased, scientifically supported reviews of skincare products. We are extremely passionate about skincare and making it accessible to all through education. We value integrity, practicality, and inclusivity. No sponsorships were received for the products prior to testing; we feel strongly about providing un-biased reviews. After blogs are published, following the links in this blog post may result in commission.
