Yusef Manufacturing Laboratories Recalls SPF Lip Moisturizers Due to Superpotent Oxybenzone Levels
Yusef Manufacturing Laboratories, LLC faced an FDA Class II recall for SPF lip moisturizers containing up to 150% of the labeled Oxybenzone. This event, now terminated, highlights critical quality control failures in contract manufacturing. Procurement and regulatory teams must scrutinize supplier potency testing and formulation adherence to mitigate significant brand and consumer safety risks.
FDA Findings: Superpotent Oxybenzone in Yusef Manufacturing Lip Moisturizers
Yusef Manufacturing Laboratories, LLC initiated a Class II recall (D-1251-2020) for its PEPPERMINT LIP MOISTURIZER, FLAVORED LIP MOISTURIZER, and standard LIP MOISTURIZER products. The critical finding by the FDA was that these SPF 15 lip balms contained up to 150% of the label claim for the active ingredient Oxybenzone. This significant deviation from specified potency levels presents a direct challenge to product safety and regulatory compliance for any entity sourcing from or distributing such products. For procurement directors, this event underscores the imperative of stringent quality control in contract manufacturing. A superpotent drug, especially an over-the-counter (OTC) product like a lip balm, can lead to increased consumer exposure to active ingredients like Oxybenzone (Benzophenone-3), potentially elevating risks of skin irritation, allergic reactions, or even systemic absorption concerns. Regulatory affairs heads must recognize that such potency excursions indicate a fundamental breakdown in formulation control, mixing homogeneity, or analytical testing protocols at the manufacturing site. The Class II classification, while not immediately life-threatening, signifies that the product could cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote, yet the commercial and reputational damage for downstream partners remains substantial.
Yusef Manufacturing Laboratories: Facility Profile and Product Reach
Yusef Manufacturing Laboratories, LLC, operating from Freeport West, F-4, #3, Clearfield, UT 84016, United States, was the manufacturer responsible for the recalled SPF 15 lip moisturizer products. The affected products, packaged in 4.2g tubes, were formulated with Oxybenzone (4%) and Octinoxate (7%) as active ingredients. The distribution pattern for these products was nationwide within the United States, indicating a broad market reach for the firm’s contract manufacturing services. This recall highlights the extensive network of private-label and white-label distribution. The products were marketed under various entities, including Bimark Inc., NOCO TRAIL REPORT, Herbruck's, St. Mark's Outpatient Surgery Center in Salt Lake City, UT, Trust Company Oklahoma, Creekside Dental in Kennewick, WA, Children's Healthcare of Atlanta Hughes Spalding, Great Smiles Orthodontics, Acceleration station, The Children's Therapy & Learning Center, Gregory P. Miller DDS FAGD in North Mankato, MN, Shelby, Carolina Custom Traders in Wake Forest, NC, Palm Springs Dental Associates Jonathan W. Preble, DMD in Altamonte Springs, FL, and Family Dental of Thornton in Thornton, CO. For business development executives, this demonstrates the pervasive nature of contract manufacturing in consumer health and the potential for a single manufacturing issue to impact a diverse array of client brands across different sectors, from healthcare to promotional goods.
Supply Chain Exposure: Implications for Downstream Distributors
The recall of 12,983 tubes of SPF lip moisturizer from Yusef Manufacturing Laboratories, distributed nationwide, exposes a significant vulnerability for the numerous downstream entities that marketed these products under their own branding or as promotional items. The diverse list of distributors, ranging from dental practices and outpatient surgery centers to children's healthcare providers and general businesses, indicates that these products permeated various consumer touchpoints. For procurement directors, this case underscores the critical importance of rigorous supplier qualification and ongoing oversight, particularly for contract manufacturers of OTC drug products. Each entity listed as a distributor, such as St. Mark's Outpatient Surgery Center or Children's Healthcare of Atlanta Hughes Spalding, faced direct reputational risk and potential consumer trust erosion by distributing a product with a significant potency deviation. Regulatory affairs heads must ensure that their organizations have robust quality agreements with contract manufacturers, including clear specifications for active ingredient potency and comprehensive testing requirements. Business development executives should recognize that such widespread recalls can create market disruption, potentially opening opportunities for manufacturers with demonstrably strong quality systems to capture market share from those impacted by compliance failures. The incident serves as a stark reminder that the responsibility for product quality extends throughout the entire supply chain, regardless of whether the product is private-labeled.
Remediation Timeline and Future Regulatory Scrutiny
The recall initiated by Yusef Manufacturing Laboratories, LLC on March 3, 2020, was officially terminated by the FDA on February 6, 2024. This termination status indicates that the FDA was satisfied with the firm's actions to remove the superpotent SPF lip moisturizer products from the market and address the root cause of the potency deviation. The lengthy period between initiation and termination, nearly four years, suggests a comprehensive process was undertaken to ensure product recovery and corrective actions were implemented and verified. For regulatory affairs and supply chain VPs, while the immediate recall is closed, the underlying quality system deficiencies that led to the superpotency of Oxybenzone remain a critical consideration. The event signals a need for enhanced scrutiny of Yusef Manufacturing Laboratories' manufacturing processes, particularly in areas of formulation control, batch consistency, and analytical testing for active pharmaceutical ingredients (APIs). Any future engagements with this contract manufacturer would necessitate heightened due diligence, including thorough on-site audits and a review of their corrective and preventive actions (CAPA) related to this specific recall. This incident serves as a reminder that even after a recall is terminated, the history of non-compliance can influence future supplier evaluations and risk assessments for procurement teams seeking reliable partners in the chemical and life sciences industry.