Cipla USA, Inc. initiated a recall of Lanreotide Injection on March 13, 2026. The recall is classified as Class II by the FDA. The affected product is Lanreotide Acetate Injection, 120 mg/0.5 mL, packaged as a single dose pre-filled syringe under NDC 69097-906-67. It is manufactured by Pharmathen International, S.A. in Rodopi, Greece, and manufactured for Cipla USA, Inc. in Warren, New Jersey.
The stated reason for the recall is lack of assurance of sterility. This followed an FDA observation at the contract manufacturing site regarding deficiencies in the site's visual inspection procedure. The recall status is listed as ongoing.
A Class II classification, per FDA definitions, indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This classification and the sterility observation are reported here as facts from the recall record, not as confirmation of harm to any patient.
Additional details on this recall, including firm-initiated actions, can be found through the FDA's recall database. Readers can consult the lanreotide compound overview for further context on this approved medication.