Cipla Lanreotide Injection Recalled for Lack of Sterility Assurance

The US Food and Drug Administration (FDA) has classified a Class II recall for lanreotide injection, 120 mg/0.5 mL, supplied as single-dose prefilled syringes (with or without safety needle), manufactured by Pharmathen International, S.A., Greece, and distributed by Cipla USA, Inc., Warren, NJ. The recall affects 54 583 syringes (for NDC 69097-870-67) and additional lots under NDC 69097-906-67, distributed nationwide in the USA. Impacted lots include 4401666IR1 (Exp. 08/31/2027) and multiple lots expiring through October 2027 (for NDC 69097-870-67), as well as additional lots expiring May through November 2026 (for NDC 69097-906-67). The recall was initiated on March 13, 2026.

The recall was initiated due to lack of assurance of sterility, following an FDA observation at the contract manufacturing site identifying deficiencies in the visual inspection procedure. The FDA classified the action as Class II on April 3, 2026, indicating that use of the affected product may cause temporary or medically reversible adverse health consequences, with a low likelihood of serious harm. While no contamination has been confirmed, compromised sterility assurance in injectable products presents a potential risk for infection or adverse reactions. Cipla notified consignees via letter; no public press release has been issued.

Lanreotide is a somatostatin analog indicated for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and is administered via deep subcutaneous injection in outpatient and specialty care settings. Because this is a sterile injectable biologic, maintaining sterility assurance is critical. Pharmacists and health care providers should identify and quarantine affected lot numbers, ensure removal from use, and coordinate with prescribers to secure alternative supply to maintain continuity of therapy in endocrine and oncology patients.

Reference

FDA. Enforcement Report. April 8, 2026. Accessed April 9, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm