Cipla USA, Inc. Initiates Class II Recall of Lanthanum Carbonate Chewable Tablets Due to Hardness Failure
Cipla USA, Inc. has initiated a Class II recall for Lanthanum Carbonate chewable tablets, 1000mg (lot NB240315), due to failed stability specifications, specifically an out-of-specification hardness test. This voluntary, nationwide recall impacts 1180 boxes, necessitating immediate action for procurement and supply chain teams to mitigate disruption and ensure patient safety within the US market.
Critical Class II Recall of Lanthanum Carbonate Chewable Tablets by Cipla USA, Inc.
Cipla USA, Inc., based in Warren, New Jersey, has initiated a voluntary Class II recall of its Lanthanum Carbonate chewable tablets, 1000mg. This significant regulatory action, identified by recall number D-0217-2026, commenced on October 24, 2025, and remains ongoing. The specific product affected is lot number NB240315, with an expiration date of December 31, 2025. A total of 1180 boxes of this critical medication, packaged as 10x9 bottles per patient pack carton (NDC 69097-936-98), have been distributed nationwide across the United States. For procurement directors and supply chain VPs, this means immediate action is required to identify and quarantine all affected stock within their distribution networks. The Class II classification indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. This necessitates a swift and thorough response to protect patient safety and maintain supply chain integrity. Business development executives should monitor market impact and potential shifts in demand for alternative Lanthanum Carbonate suppliers.
Root Cause: Failed Stability Specifications for Hardness Test
The primary reason for this recall is the product's failure to meet stability specifications, specifically being out of specification for the hardness test. This deviation from quality standards is critical for a chewable tablet formulation, as it can impact drug release, dissolution, and ultimately, therapeutic efficacy. For regulatory affairs heads, this highlights a fundamental quality control breakdown that requires a comprehensive root cause analysis and corrective and preventive actions (CAPA) plan. An out-of-specification (OOS) result for hardness suggests potential issues in the manufacturing process, formulation stability, or packaging integrity over time. Procurement teams must understand that such quality failures can lead to product non-compliance and necessitate costly recall logistics, including reverse distribution and destruction. This event underscores the importance of robust quality agreements and ongoing stability monitoring programs with contract manufacturers to mitigate supply chain risks and ensure product quality throughout its shelf life.
Manufacturing and Distribution Chain for Recalled Lanthanum Carbonate
The recalled Lanthanum Carbonate chewable tablets were manufactured by Invagen Pharmaceuticals, Inc., located in Hauppauge, New York 11786, for Cipla USA, Inc., the recalling firm based in Warren, New Jersey 07059. This multi-entity arrangement is common in the pharmaceutical industry, but it places significant responsibility on both the contract manufacturer and the marketing authorization holder. For procurement directors, this structure emphasizes the need for rigorous due diligence and continuous oversight of contract manufacturing organizations (CMOs). Supply chain VPs must recognize that quality issues at the manufacturing site, even if not directly owned by the recalling firm, directly impact their operations and market reputation. The nationwide distribution pattern in the USA means that the logistical challenges of retrieval and replacement are substantial, affecting numerous pharmacies, hospitals, and ultimately, patients across the country. Business development executives should assess how this event might influence future partnerships and supplier selection criteria, emphasizing quality and compliance track records.