FDA Class II Recall: Pro Numb Tattoo Numbing Spray LLC's Topical Anesthetic Pulled Due to cGMP Deviations
Pro Numb Tattoo Numbing Spray LLC has initiated a Class II recall for its PRO NUMB Tattoo Numbing Spray nationwide due to cGMP deviations. This regulatory event highlights critical quality control failures for a Lidocaine and Epinephrine topical drug, posing significant supply chain and compliance risks for procurement and regulatory teams in the chemical and life sciences industry.
FDA Class II Recall: Pro Numb's cGMP Deviations Impact Topical Anesthetic Supply
Pro Numb Tattoo Numbing Spray LLC has initiated a nationwide Class II recall for its PRO NUMB Tattoo Numbing Spray, a human over-the-counter (OTC) drug containing Lidocaine Hydrochloride and Epinephrine Hydrochloride. This critical regulatory action, identified as recall number D-0302-2026 and initiated on February 2, 2026, stems directly from deviations in current Good Manufacturing Practices (cGMP). For procurement directors and supply chain VPs, this means an immediate re-evaluation of sourcing channels for topical anesthetic formulations, particularly those relying on Lidocaine and Epinephrine. The presence of cGMP deviations indicates fundamental failures in quality control, potentially compromising product safety, efficacy, and sterility, which are non-negotiable for drug products. The affected batches include Lot Numbers J01 through J14 and J55 through J69. The recall's Class II classification signifies that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This necessitates prompt action from any entity involved in the distribution or use of these specific lots to prevent patient exposure and potential liabilities. Business development executives should note the reputational damage and market disruption associated with such cGMP non-compliance, impacting consumer trust and competitive positioning for similar products.
Facility Profile: Pro Numb Tattoo Numbing Spray LLC's Manufacturing and Distribution Footprint
Pro Numb Tattoo Numbing Spray LLC, based in Palm Bay, Florida, United States, is the entity responsible for the manufacturing and distribution of the recalled PRO NUMB Tattoo Numbing Spray. The product, available in 1 FL OZ (28.4 ML) and 4 OZ (120 mL) bottles under NDC 83389-111-11, is classified as a human OTC drug administered via the topical route. While specific details regarding the facility's FEI number, production capacity, or key markets beyond nationwide U.S. distribution are not disclosed in the available intelligence, the company's role as both manufacturer and distributor places direct responsibility for cGMP adherence squarely on its operations in Palm Bay, FL. For regulatory affairs heads, this highlights the importance of comprehensive due diligence on contract manufacturing organizations (CMOs) or own-brand label manufacturers, even for seemingly straightforward topical formulations. The lack of granular facility data underscores a broader challenge in supply chain transparency, making it difficult for downstream partners to fully assess risk exposure. Procurement teams must recognize that even smaller manufacturers of specialized topical products are subject to stringent FDA cGMP requirements, and non-compliance can lead to significant supply interruptions and regulatory scrutiny.
Supply Chain Exposure: Risks in the Topical Anesthetic Market
The recall of PRO NUMB Tattoo Numbing Spray due to cGMP deviations creates immediate supply chain exposure for any business relying on Pro Numb Tattoo Numbing Spray LLC for Lidocaine Hydrochloride and Epinephrine Hydrochloride topical products. Given the product's nationwide distribution in the USA, a broad range of tattoo parlors, aesthetic clinics, and potentially retail pharmacies could be affected. For procurement directors, this event necessitates an urgent review of current inventory, supplier contracts, and contingency plans for topical anesthetics. The broader market for Lidocaine-based products has seen similar challenges; for instance, Spectra Medical Devices faced a Class II recall for its Lidocaine HCl Injection on June 10, 2026, also due to sterility assurance deficiencies. This parallel event underscores a systemic vulnerability within the manufacturing practices for local anesthetics, suggesting that quality control issues are not isolated incidents but potentially broader industry challenges. Supply chain VPs must consider the ripple effect of such recalls, which can lead to product shortages, increased costs for alternative sourcing, and potential delays in patient care or service delivery. The commercial impact extends beyond direct financial losses to include brand erosion and loss of market share if alternative, compliant supplies cannot be rapidly secured.
Alternative Suppliers: Mitigating Risk for Lidocaine and Epinephrine Formulations
In light of Pro Numb Tattoo Numbing Spray LLC's cGMP-driven recall, procurement teams must proactively identify and qualify alternative suppliers for Lidocaine Hydrochloride and Epinephrine Hydrochloride topical formulations. While the ChemLifeIntel Knowledge Graph does not specify direct alternatives for Pro Numb, the market for topical anesthetics is diverse. Key considerations for sourcing include manufacturers with a robust history of FDA compliance, demonstrated cGMP adherence, and established quality management systems. Companies like Akorn Operating Company LLC, Sandoz Inc., and Teva Pharmaceuticals are known players in the broader sterile and topical drug markets, though specific Lidocaine/Epinephrine topical products from them would require direct verification. Regulatory affairs heads should prioritize suppliers that can provide comprehensive documentation, including audit reports, stability data, and certificates of analysis, ensuring full traceability and compliance. Geographic diversification of suppliers, beyond a single country or region, can also reduce vulnerability to localized regulatory actions or supply disruptions. Qualification timelines for new suppliers, particularly for drug products, can range from 6 to 18 months, emphasizing the urgency of initiating this process immediately to prevent prolonged supply gaps and maintain business continuity.
Pro Numb Tattoo Numbing Spray LLC's Regulatory History and Compliance Outlook
The ChemLifeIntel Knowledge Graph does not indicate any prior FDA enforcement actions, such as Warning Letters, 483s, or Import Alerts, specifically against Pro Numb Tattoo Numbing Spray LLC. This voluntary Class II recall, initiated by the firm itself, therefore represents a significant and potentially foundational regulatory event for the company. For regulatory affairs heads, this situation underscores that even a company without a prior public compliance record can face severe regulatory challenges. The cGMP deviations leading to this recall will undoubtedly place Pro Numb Tattoo Numbing Spray LLC under heightened FDA scrutiny. While the recall is firm-initiated, the underlying cGMP issues will require a thorough investigation and implementation of comprehensive corrective and preventive actions (CAPA). Failure to adequately address these deviations could lead to further FDA enforcement, including potential Warning Letters, injunctions, or even product seizures. Business development executives should recognize that a clean regulatory history can quickly be marred by a single significant recall, impacting future market access, partnerships, and investor confidence. The ongoing status of recall D-0302-2026 means that the firm's actions and the FDA's oversight are still in progress.
Remediation Timeline and Future Regulatory Scrutiny for Topical Drug Manufacturers
As the Class II recall for PRO NUMB Tattoo Numbing Spray remains ongoing, Pro Numb Tattoo Numbing Spray LLC is obligated to conduct a thorough investigation into the root causes of the cGMP deviations and implement robust corrective actions. For regulatory affairs heads, understanding this remediation timeline is crucial. The FDA will expect detailed responses outlining how the company plans to prevent recurrence, including process improvements, personnel training, and enhanced quality oversight. This typically involves a comprehensive CAPA plan, which can take several months to fully implement and validate. The FDA will monitor the effectiveness of these actions, potentially through follow-up inspections. While the immediate risk of an Import Alert is low given the domestic location, continued non-compliance could escalate to more severe enforcement measures. This event serves as a critical reminder for all manufacturers of OTC topical drugs that adherence to cGMP is not merely a regulatory formality but a fundamental requirement for product quality and patient safety. Supply chain VPs should anticipate potential delays in product availability from any supplier undergoing similar remediation, emphasizing the need for diversified sourcing and proactive risk management strategies across the entire chemical and life sciences industry.