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Lanreotide Injection 120 mg/0.5 mL
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DRUG RECALLMODERATE

Lanreotide Injection 120 mg/0.5 mL

Cipla is recalling Lanreotide Injection 120 mg/0.5 mL due to a lack of assurance of sterility.

What to do

Contact your healthcare provider if you have concerns about your medication. Do not use the product if you have questions regarding its sterility.

Posted
Updated
Recall No.
D-0423-2026
Agency
Firm
Cipla USA, Inc.
Recall ID
98575
Status
ONGOING

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.

How to identify it

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

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification