AvKARE Initiates Nationwide Class II Recall of Norgestimate and Ethinyl Estradiol Tablets Over Content Uniformity Failure
AvKARE has initiated a nationwide Class II recall of 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets due to failed content uniformity specifications. This event, originating from their Pulaski, TN facility, highlights critical quality control vulnerabilities. Procurement and regulatory teams must assess immediate supply chain risks and AvKARE's extensive history of compliance issues.
FDA-Mandated Recall: AvKARE's Norgestimate and Ethinyl Estradiol Content Uniformity Failure
AvKARE, a U.S.-based pharmaceutical company, has initiated a voluntary, firm-initiated Class II recall of 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets, USP. This critical action, designated recall number D-0007-2026, was prompted by the product's failure to meet established content uniformity specifications. The affected lot, # LF41138A, with an expiration date of June 30, 2027, was distributed nationwide across the United States. The recall was initiated on September 2, 2025, with the FDA classifying the event on October 6, 2025, and reporting it on October 15, 2025. For procurement directors, this failure in content uniformity is a severe quality control breach. It signifies that the active pharmaceutical ingredients, Norgestimate and Ethinyl Estradiol, are not evenly distributed throughout each tablet. Inconsistent dosing can lead to significant clinical implications, including reduced contraceptive efficacy, potentially resulting in unintended pregnancies, or an increased risk of adverse effects if certain tablets contain higher than intended concentrations. This directly impacts patient safety and product reliability, demanding immediate attention from supply chain and regulatory compliance teams to assess the integrity of AvKARE's manufacturing processes.
AvKARE's Operational Footprint and Impacted Product Portfolio
The recalled Norgestimate and Ethinyl Estradiol Tablets were manufactured for AvKARE at their facility located at 615 N 1st St, Pulaski, TN 38478-2403, within the United States. This facility is central to AvKARE's manufacturing operations. The specific product involved, identified by ANDA091232, Carton NDC 42291-565-84, and Blister NDC 42291-565-28, is a combination oral contraceptive available in varying dosages: 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg. As a human prescription drug, its failure to meet quality standards has widespread implications. This product is critical within the Genitourinary & Hormones therapeutic area. For business development executives, understanding AvKARE's broader product portfolio is essential. The company is known to handle a diverse range of generic pharmaceuticals, including products like Pregabalin, Chloroquine Phosphate, and Mirtazapine. The current recall, while specific to Norgestimate and Ethinyl Estradiol, raises questions about the robustness of quality assurance across AvKARE's entire manufacturing output. This necessitates a comprehensive review of all products sourced from or distributed by AvKARE to proactively identify potential risks.
Supply Chain Exposure: Mitigating Risks for Norgestimate and Ethinyl Estradiol Buyers
The nationwide distribution of 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets means that procurement directors and supply chain VPs across the U.S. are directly impacted by this Class II recall. The immediate consequence is a disruption in the supply of a commonly prescribed oral contraceptive, necessitating urgent action to prevent stockouts and ensure continuity of patient access. The failure in content uniformity is not merely a technical issue; it reflects a fundamental flaw in manufacturing quality control that can undermine trust in the product and the supplier. Regulatory affairs heads must consider the implications for product registration and market availability. Any downstream formulators or distributors relying on AvKARE for this specific molecule or similar products face heightened scrutiny. The commercial grounding of this event lies in the potential for significant financial and reputational damage for all parties in the supply chain. Companies must swiftly identify their exposure, quantify the affected inventory, and implement recall procedures, while simultaneously seeking alternative, qualified sources to stabilize their supply lines and reassure healthcare providers and patients.
Strategic Sourcing: Identifying Alternative Norgestimate and Ethinyl Estradiol Suppliers
To mitigate the supply chain vulnerabilities exposed by AvKARE's recurring quality issues, procurement teams must prioritize the identification and qualification of alternative suppliers for Norgestimate and Ethinyl Estradiol. The ChemLifeIntel Knowledge Graph provides actionable intelligence on several potential manufacturers capable of supplying these critical molecules. These include Aurohealth, Granules India (India), NorthStar Rx, NURAY CHEMICALS, Indoco Remedies (India), Armas Pharmaceuticals (India), Societal CDMO Gainesville, and Apotex (Canada). Diversifying the supplier base geographically, incorporating manufacturers from regions such as India and Canada, can significantly enhance supply chain resilience against localized disruptions or single-source failures. Regulatory affairs teams will play a crucial role in expediting the qualification process for these alternative suppliers, ensuring that their products meet stringent FDA regulatory standards and bioequivalence requirements for ANDA091232. This proactive approach is vital for maintaining consistent market supply and minimizing the impact on patient care, while also reducing reliance on suppliers with a documented history of quality control challenges.
AvKARE's Pattern of Regulatory Non-Compliance and Escalating Risk Profile
This recall of Norgestimate and Ethinyl Estradiol Tablets is not an isolated event but rather another instance in AvKARE's extensive and concerning history of regulatory non-compliance. Since January 2020, AvKARE has been associated with at least seven other significant recalls, painting a clear picture of systemic quality control deficiencies. In January 2020, a Dutasteride recall highlighted impurity failures, followed by a Lamotrigine recall in June 2020 due to foreign substance contamination. A high-severity Class I recall in December 2020 involved a Trazodone-Sildenafil mix-up at a third-party facility, underscoring broader supply chain oversight issues. More recently, AvKARE initiated a Class II recall of Cinacalcet Tablets in December 2024 over nitrosamine impurity concerns and a Carboxymethylcellulose Sodium Ophthalmic Solution recall in January 2025 due to a label mix-up. Just months prior to the current event, in June 2025, Celecoxib Capsules were recalled for Tadalafil cross-contamination, and in September 2025, Chlorpromazine Hydrochloride faced a recall for foreign substance presence. This recurring pattern of quality lapses—ranging from content uniformity and impurities to foreign substances and product mix-ups—signals deep-seated vulnerabilities in AvKARE's quality management systems. For regulatory affairs heads and business development executives, this history significantly elevates AvKARE's risk profile as a supplier and partner, demanding rigorous due diligence and continuous monitoring.
Remediation Timeline and Future Regulatory Oversight for AvKARE Operations
The ongoing Class II recall of Norgestimate and Ethinyl Estradiol Tablets, initiated by AvKARE on September 2, 2025, places the company under heightened scrutiny from the FDA. As a voluntary, firm-initiated action, AvKARE is responsible for the complete execution of the recall, including notifying affected parties and managing product returns. Crucially, the firm must conduct a thorough investigation into the root cause of the "Failed Content Uniformity Specifications" at its Pulaski, TN facility and implement robust corrective and preventive actions (CAPA) to prevent recurrence. Given AvKARE's documented history of multiple quality-related recalls, regulatory affairs heads should anticipate that the FDA will closely monitor these remediation efforts. There is an increased likelihood of further FDA inspections, potentially leading to additional enforcement actions such as Warning Letters, consent decrees, or even an Import Alert if the agency deems the systemic issues unaddressed or the CAPA inadequate. For supply chain VPs, this ongoing regulatory pressure signals potential long-term instability in AvKARE's operational reliability, necessitating strategic contingency planning and a re-evaluation of all current and future sourcing agreements with the company.