Lanreotide Injection recalled over sterility concerns

Recall date

March 13, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cipla USA, Inc. recalls Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pha…

Recall number

D-0423-2026

FDA classification

Class II

Brand / firm

Cipla USA, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, 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 69097-906-67