Graviti Pharmaceuticals Faces Second Class II Recall for Furosemide Due to Foreign Substance Contamination, Impacting Rising Pharma Supply
Graviti Pharmaceuticals Private Limited has initiated a Class II recall for Furosemide Tablets, USP 40 mg, due to a foreign substance, affecting 4,212 bottles distributed by Rising Pharma Holdings, Inc. This marks Graviti's second Class II recall in recent months, signaling escalating quality control deficiencies and significant supply chain risks for partners sourcing from their Hyderabad, India facility.
FDA Mandates Class II Recall for Graviti Pharmaceuticals' Furosemide Due to Foreign Substance
Graviti Pharmaceuticals Private Limited, based in Hyderabad, India, has initiated a voluntary Class II recall (D-0293-2026) for 4,212 bottles of Furosemide Tablets, USP 40 mg. This critical action, reported on January 28, 2026, stems from the confirmed presence of a foreign substance within Lot# FUB125042G, which carries an expiration date of May 13, 2027. The affected product, identified by NDC 64980-563-10, was manufactured by Graviti Pharmaceuticals for Rising Pharmaceuticals Inc. of East Brunswick, NJ, and distributed nationwide across the U.S. This incident directly impacts procurement directors and supply chain VPs reliant on Graviti for generic drug supply, necessitating immediate assessment of current inventory and potential disruption to patient access for this essential loop diuretic. 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, but still warrants urgent corrective action. For business development executives, this event highlights the inherent risks in partnerships with manufacturers exhibiting recurring quality control challenges.
Graviti Pharmaceuticals' Manufacturing Role and Furosemide's Market Significance
Graviti Pharmaceuticals Private Limited operates as a key manufacturer from its facility at E & 621 Patancheru Mandal, Isnapur Village Rd, Survey No 621, Telangana - 502307, India. This facility is responsible for producing finished dosage forms, including the recalled Furosemide Tablets, USP 40 mg. Furosemide, a widely prescribed loop diuretic, is critical for managing conditions such as edema associated with congestive heart failure, liver cirrhosis, and renal disease, as well as hypertension. Its broad application means any supply disruption has significant clinical and commercial implications. For procurement directors, understanding Graviti's role as a contract manufacturer for entities like Rising Pharmaceuticals Inc. is crucial; while Rising Pharma holds the application number ANDA216629 and distributes the product, Graviti's manufacturing quality directly impacts Rising's brand integrity and supply continuity. This event underscores the necessity for rigorous due diligence on contract manufacturing organizations (CMOs) in high-volume generic markets, particularly for essential medicines where supply stability is paramount.
Supply Chain Exposure: Rising Pharma and U.S. Nationwide Distribution Impact
The recall of Furosemide Tablets, USP 40 mg, manufactured by Graviti Pharmaceuticals for Rising Pharmaceuticals Inc., creates immediate supply chain exposure for Rising Pharma and the U.S. healthcare system. With 4,212 bottles of the 1,000-count presentation (NDC 64980-563-10) distributed nationwide, procurement teams at hospitals, pharmacies, and wholesale distributors must rapidly identify and quarantine affected stock. This event means Rising Pharma faces potential revenue loss, reputational damage, and the immediate operational burden of managing a nationwide recall. For other companies sourcing active pharmaceutical ingredients (APIs) or finished products from Graviti, this incident serves as a critical warning. Regulatory affairs heads must assess their own product portfolios for any reliance on Graviti and proactively review quality agreements. Business development executives should re-evaluate the risk profile of any potential or existing partnerships with manufacturers in regions experiencing frequent quality control issues, as such events can severely impact market access and product availability.
Graviti Pharmaceuticals' Escalating Regulatory Compliance Record
This Furosemide recall marks a concerning pattern in Graviti Pharmaceuticals Private Limited's regulatory compliance history. Just three months prior, on October 29, 2025, Graviti initiated a Class II recall for Bupropion Hydrochloride ER 300mg due to failed specifications. The current recall, initiated on January 10, 2026, for Furosemide due to a foreign substance, indicates a systemic issue with quality control and manufacturing processes at their Hyderabad facility. For regulatory affairs heads, two Class II recalls within a short timeframe from the same manufacturer signal a heightened risk of further FDA scrutiny, including potential Warning Letters, increased inspections, and even Import Alerts. Supply chain VPs must recognize that this trend elevates Graviti's risk profile significantly, demanding immediate re-evaluation of all products sourced from this manufacturer. The recurrence of serious quality deficiencies suggests that previous corrective actions, if any, were insufficient, posing a continuous threat to product quality and patient safety across their distributed portfolio.
Mitigating Supply Chain Risk: Identifying Alternative Furosemide Suppliers
Given Graviti Pharmaceuticals' recurring quality issues, procurement directors must prioritize identifying and qualifying alternative suppliers for Furosemide and any other molecules sourced from their facility. While specific alternative suppliers are not detailed in our current intelligence, the market for generic Furosemide is generally competitive, offering multiple potential manufacturers. Key considerations for procurement teams include assessing the regulatory history of prospective suppliers, verifying their manufacturing capabilities, and ensuring robust quality management systems are in place. Geographic diversification of the supply base is also critical to mitigate regional risks, such as those associated with manufacturing in India, which has seen several recent recalls. Qualification timelines for new suppliers can range from 6 to 18 months, depending on the complexity of the product and the regulatory requirements, underscoring the urgency for immediate action. Business development executives should explore strategic partnerships with manufacturers demonstrating consistent compliance and a strong track record to build resilient supply chains.
Immediate Actions and Future Regulatory Scrutiny for Graviti Pharmaceuticals
The ongoing Class II recall for Furosemide Tablets places Graviti Pharmaceuticals Private Limited under intensified regulatory scrutiny by the FDA. As the recall is firm-initiated and voluntary, Graviti is expected to conduct a thorough investigation into the root cause of the foreign substance contamination and implement comprehensive corrective and preventive actions (CAPA). For regulatory affairs heads, the immediate priority is to ensure Graviti's CAPA plan is robust and addresses not only the specific Furosemide issue but also the underlying systemic quality deficiencies highlighted by their previous Bupropion recall. Failure to adequately address these issues could lead to escalated enforcement actions, including an official FDA Warning Letter, increased frequency of inspections, or even an Import Alert, which would effectively bar all products from Graviti's Hyderabad facility from entering the U.S. market. Supply chain VPs must prepare for potential long-term disruptions and actively monitor FDA updates regarding Graviti's compliance status to safeguard their product supply and market continuity.