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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 recalls Lanreotide Injection 120 mg/0.5 mL over sterility assurance concerns.

What to do

Check your product for NDC 69097-906-67. Do not use the affected injection. Contact Cipla USA for return and replacement instructions.

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

Why it was recalled

Cipla USA is recalling Lanreotide Injection, 120 mg/0.5 mL, due to a lack of assurance of sterility from deficiencies in the visual inspection procedure at the contract manufacturing site.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

ProductRecall #
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 69097-906-67D-0423-2026
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: 69097-870-67D-0422-2026

Where it was sold

Distributed nationwide.

Other recent recalls from Cipla USA, Inc.

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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification