Lanreotide Injection Recalled (Class II) Over Particulate Matter

On January 2, 2026, Cipla USA, Inc. initiated a recall of Lanreotide Injection, 120 mg/0.5 mL, supplied in a pre-filled syringe for deep subcutaneous injection. The recall, identified as D-0290-2026, has been classified by the FDA as Class II. The stated reason for the recall is the presence of particulate matter in the product. The affected product carries NDC 69097-870-67 and is manufactured for Cipla USA, Inc., based in Warren, New Jersey. According to the latest available information, this recall is ongoing. Class II recalls are used by the FDA to designate situations in which 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 reason for recall are being reported as stated in the FDA recall record and do not by themselves indicate that harm has occurred. Additional details regarding the scope or distribution of the recalled lots were not provided in the available event data. Readers seeking general background on lanreotide, including its approved uses and regulatory status, can consult the compound overview for further context.