FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Cipla Lanreotide Injection 120 mg recalled for sterility assurance defect
OTHERNationwide distribution
Stop using Cipla Lanreotide Injection
Cipla USA is recalling specific lots of Lanreotide Injection (120 mg) because the manufacturer did not follow proper visual inspection procedures during production. This means the medication may not meet sterility standards and could potentially be contaminated.
- Check if you have Lanreotide Injection with one of the recalled lot numbers listed on the FDA website or your pharmacy receipt.
- Do not use recalled doses. Contact your doctor or pharmacist immediately for instructions on what to do.
- If you have already used this medication, call your doctor to discuss any health concerns.
Hazard
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Sold states
Nationwide in the USA
Manufactured in
10 Independence Blvd, Warren, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0423-2026More Cipla USA, Inc. recalls
- FDA-Drug2026-04-22Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for elevated N-Nitroso impurity
- FDA-Drug2026-04-22Cipla cinacalcet 90 mg tablets recalled for elevated impurity levels
- FDA-Drug2026-04-22Cipla USA Cinacalcet Hydrochloride 60 mg tablets recalled for elevated nitrosamine impurity
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility concerns
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