AvKARE Initiates Nationwide Class II Recall of Chlorpromazine Hydrochloride Due to Foreign Substance
AvKARE has initiated a nationwide Class II recall of 1,512 cartons of Chlorpromazine Hydrochloride Tablets, 50 mg, due to foreign substance contamination. This event, impacting a critical CNS medication, necessitates immediate supply chain risk assessment for procurement and regulatory teams, underscoring AvKARE's persistent quality control challenges and the need for diversified sourcing strategies.
AvKARE's Class II Recall of Chlorpromazine Hydrochloride Due to Foreign Substance
AvKARE, based in Pulaski, TN, has initiated a nationwide Class II voluntary recall (D-0643-2025) for specific lots of its Chlorpromazine Hydrochloride Tablets, USP, 50 mg. This action, communicated initially via email on August 25, 2025, stems from the confirmed presence of a foreign substance within the product. The recall affects 1,512 cartons, specifically Lot # 46824 with an expiration date of September 30, 2025, and Lot # 47171 expiring on December 31, 2025. Each carton contains 50 tablets in a 5x10 unit dose configuration, identified by NDC 50268-164-15. For procurement directors and regulatory affairs heads, this recall of a human prescription drug, indicated for oral administration, signals an immediate need to quarantine affected inventory and assess the continuity of supply for Chlorpromazine Hydrochloride, a critical medication in the Central Nervous System (CNS) therapeutic area. The Class II classification indicates that the foreign substance could cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. This necessitates prompt action to mitigate patient safety risks and ensure compliance with FDA directives, particularly given the nationwide distribution pattern across the United States.
AvKARE's Operational Footprint and Diverse Product Portfolio
AvKARE, operating from Pulaski, TN, functions as a manufacturer and distributor within the pharmaceutical supply chain. While our intelligence currently assigns a 'low' risk band to the company, its recent recall history suggests a need for closer scrutiny. The company is responsible for a diverse portfolio of generic pharmaceutical products, including various molecules across multiple therapeutic areas. While the specific manufacturing facility for Chlorpromazine Hydrochloride is not detailed, AvKARE's Pulaski site is identified as a formulation facility. This recall, involving a product under ANDA209755, underscores the challenges in maintaining stringent quality control across a broad product range. For business development executives and supply chain VPs, understanding AvKARE's operational scope is crucial. Their product offerings extend beyond CNS medications like Chlorpromazine Hydrochloride to include anti-infectives such as Azithromycin, cardiovascular drugs like Valsartan, and oncology treatments such as Abiraterone. This wide array means that quality issues at AvKARE can have ripple effects across multiple therapeutic markets. The recurrence of foreign substance contamination, as seen previously with Lamotrigine, indicates systemic vulnerabilities in their quality management systems that warrant careful consideration when evaluating AvKARE as a supplier or partner.
Supply Chain Exposure: Immediate Actions for Chlorpromazine Hydrochloride Procurement
The nationwide distribution of AvKARE's recalled Chlorpromazine Hydrochloride Tablets means that pharmaceutical distributors, pharmacies, and healthcare providers across the United States are directly impacted. Procurement directors must immediately assess their current inventory levels of AvKARE's Chlorpromazine Hydrochloride, specifically checking for Lot # 46824 and Lot # 47171. Failure to promptly identify and quarantine affected stock could lead to regulatory non-compliance and potential patient safety incidents, incurring significant financial and reputational damage. For supply chain VPs, this event highlights the critical importance of supplier diversification, even for generic medications. Reliance on a single supplier like AvKARE, especially one with a documented history of quality issues, introduces inherent risks. The recall of 1,512 cartons, while not a massive volume, can still create localized shortages or necessitate urgent re-sourcing efforts, particularly for a drug like Chlorpromazine Hydrochloride which is essential for managing psychiatric conditions. Business continuity plans must account for such disruptions, prioritizing rapid qualification of alternative suppliers to maintain patient access and market stability.
Identifying Alternative Sourcing for Chlorpromazine Hydrochloride
In light of AvKARE's recall, procurement teams must proactively identify and qualify alternative suppliers for Chlorpromazine Hydrochloride to ensure uninterrupted supply. While specific alternative suppliers for Chlorpromazine Hydrochloride are not explicitly detailed in our knowledge graph, general alternative suppliers for various products AvKARE handles include established entities such as Granules India, Apotex (Canada), Aurohealth, NorthStar Rx, NURAY CHEMICALS, Indoco Remedies, Armas Pharmaceuticals (India), and Societal CDMO Gainesville. These companies represent potential avenues for diversification across different geographies, including North America and Asia. Regulatory affairs heads should note that qualifying new suppliers involves rigorous due diligence, including facility audits, review of regulatory history, and analytical testing to ensure product quality and bioequivalence for ANDA209755. Qualification timelines can range from several months to over a year, depending on the complexity of the product and the regulatory requirements of the target markets. Expedited qualification processes may be necessary, but these must not compromise quality standards. Engaging with multiple potential suppliers simultaneously is a prudent strategy to mitigate single-source dependencies and build resilience into the supply chain for critical CNS medications.
AvKARE's Recurring Compliance Challenges: A Pattern of Quality Failures
This recall of Chlorpromazine Hydrochloride is not an isolated incident for AvKARE; it is the latest in a series of significant quality and compliance issues that underscore systemic vulnerabilities within the company's operations. Our intelligence shows a concerning pattern of recalls since 2020. In January 2020, AvKARE initiated a recall of Dutasteride due to impurity failures. This was followed by a Lamotrigine recall in June 2020, also due to foreign substance contamination, mirroring the current Chlorpromazine Hydrochloride issue. A high-severity Class I recall occurred in December 2020 for a Trazodone-Sildenafil mix-up at a third-party facility, indicating potential gaps in contract manufacturing oversight. More recently, AvKARE faced a high-severity recall of Cinacalcet Tablets in December 2024 over nitrosamine impurity concerns, and a low-severity recall of Carboxymethylcellulose Sodium Ophthalmic Solution in January 2025 due to a label mix-up. Just two months prior to the current event, in June 2025, Celecoxib Capsules were recalled over Tadalafil cross-contamination. This consistent string of quality deviations—ranging from foreign substances and impurities to product mix-ups and cross-contamination—suggests a deeply entrenched problem in AvKARE's quality management systems and manufacturing controls. For regulatory affairs and procurement teams, this history elevates AvKARE's risk profile significantly, demanding heightened scrutiny of all products sourced from or distributed by the company.
Regulatory Outlook and Future Actions for AvKARE
The "Ongoing" status of this Class II recall for Chlorpromazine Hydrochloride indicates that the FDA's assessment and AvKARE's corrective actions are still in progress. Given AvKARE's extensive history of quality-related recalls, including multiple instances of foreign substance contamination and cross-contamination, the FDA is likely to intensify its oversight. Regulatory affairs heads should anticipate increased scrutiny, potentially leading to further inspections of AvKARE's facilities in Pulaski, TN, and any contract manufacturing sites involved in their supply chain. For AvKARE, a comprehensive and robust remediation plan is imperative. This plan must address the root causes of foreign substance ingress, implement enhanced quality control measures, and demonstrate sustainable improvements across all manufacturing and distribution processes. Failure to adequately address these systemic issues could escalate regulatory actions, including potential Warning Letters, product seizure, or even an Import Alert if foreign-sourced components are implicated. Business development executives considering partnerships with AvKARE must factor in this elevated regulatory risk, as ongoing compliance issues can severely impact market access and product launches. Procurement teams should prepare for potential long-term supply disruptions from AvKARE and actively pursue alternative sourcing strategies.