Cipla USA, Inc. recalls Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only,
Recalled April 15, 2026 · FDA recall D-0422-2026 · Cipla USA
Hazard
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. · FDA Class II
Units
54,583 syringes
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Product
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Manufacturer(s)
Cipla USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →