Cipla USA, Inc. initiated a Class II recall of Lanreotide Acetate Injection on March 13, 2026. The recall covers Lanreotide Injection, 120 mg per 0.5 mL, packaged as a box with one pre-filled syringe and one safety needle, listed for single dose use only under NDC 69097-870-67. The product is manufactured by Pharmathen International, S.A. in Rodopi, Greece, and manufactured for Cipla USA, Inc. of 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 identifying deficiencies in its visual inspection procedure. The recall is classified as Class II by the FDA.
According to the recall record, the status of this action is ongoing. The recall was initiated on March 13, 2026, per the available data.
This information reflects only the details provided in the recall record, including the classification, reason, recalling firm, and initiation date. No additional details about distribution scope or patient impact are included here. Readers can consult the compound overview for further context on lanreotide.