The United States Food and Drug Administration issued an alert and recall nationwide for Porcelana Whitening Night Cream-a kind of cosmetic product that had dangerously high levels of mercury contaminating its skin program, which was prohibited by federal law, in 2025. The recall was prompted by a stream of health complaints and consequent laboratory analyses that confirmed the mercury content exceeded the FDA’s permissible threshold for such cosmetic products. Recalled is a Class I-product, which means it could cause potentially serious adverse health effects, especially in long-term users. [1]
Mercury and its compounds in cosmetics are strictly regulated in the European Union under the Cosmetic Products Regulation (EC) No. 1223/2009. This is so because it permits the use of the substances only in traces, as far as possible, when made unavoidable. Such an incident only tests the call for traceability and thus enforcement of post-market surveillance for a brand, such as Porcelana, which is not exactly a household name in the EU. The European Commission hopes to enhance consumer protection from harmful compounds that may find their way into personal care products via its new direction on risk-based market surveillance, as reiterated in the updated 2024 RAPEX guidelines. [2]
Being a skin lighting agent, mercury poses a critical public health risk through dermal absorption and systemic toxicity. The Porcelana Whitening Night Cream bottled mercury levels with immense values that far exceeded the FDA’s limit of 1 ppm (parts per million). Chronic exposure has been known to lead to mercury poisoning manifested by symptoms such as skin rashes, nephrotoxicity, and neurotoxicity. Especially, children, pregnant women, and those who are compromised with immunity are at greater risk. The recall followed the FDA’s confirmation via testing that samples from the product showed mercury levels of as high as 12,000 ppm, signifying a gross violation of federal safety standards. [3]
This regulatory violation was usually due to an FDA investigation that was triggered by consumer complaints from California and Texas. Lab tests of samples from the states proved that mercury was there. Traceback investigations showed that the product manufactured in Mexico had come to the U.S. without declaring the validating oringredients for the formulation. The responsible party has not registered under MoCRA, Modernization of Cosmetics Regulation Act 2022, which now mandates complete ingredient disclosure and safety substantiation for all sold cosmetics. [4]
Mercury-elemental and inorganic forms-the FDA issued import alerts of undocumented cosmetic products manufactured like the one mentioned above, but without death as other consequences. Symptoms ranging from neurological disturbances to fatigue and kidney malfunction were reported by more than a dozen consumers. The FDA took immediate action to withdraw the product from all types of retail channels. [5]
Brand Name: Porcelana
Name of the product: Whitening Night Cream
Product Origin: Mexico
Packaging Type: Small plastic cosmetic jars (57g or 2 oz.)
Issue: Toxic mercury levels found beyond federal safety limits ascertain evil consequence
The FDA’s Enforcement Report initiated recall after independent laboratory tests conducted by California Department of Public Health (CDPH) and Texas Department of State Health Services (DSHS) confirmed high mercury content in the cream. The cream contains no compounds listed as mercury in its ingredient list, thus flouting 21 CFR §700.13, which prohibits the use of mercury in any skin-lightening or anti-aging product without specific FDA allowance. [3]
The distributors, Porcelana Products Inc., through the recall notification, advised consumers to:
With that, the manufacturer also committed to:
This case thus increases the necessity for the compliance enforcement in the trans-border cosmetic trade. According to Food Research Lab, a safety evaluation of cosmetic formulations along with traceability in ingredient sourcing is now a must, mandating compliance with MoCRA and FDA guidelines as a norm rather than an exception. Also, high-risk cosmetic categories like skin lightening agents should carry out routine toxicological screening and contaminant profiling before they hit the markets.
Food Research Lab can help fully in the cosmetic manufacture compliance by providing guidance as follows:
The Porcelana Night Cream recall of 2025 exhibits gaping voids in ingredient transparency, manufacturing surveillance, and importer accountability in the entire cosmetic industry. It teaches urgency for brands to comply with and adapt to evolving regulatory frameworks like MoCRA, and to have precaution testing procedures established to enhance public health. FRL adjoins support into toxicological risk assessments, contaminant testing, and MoCRA compliance auditing for market readiness for cosmetic brands.
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