FDA-Drug2026-01-21Class IIPROCESSING DEFECT
Cipla Lanreotide Injection 120 mg recalled for particulate matter
Nationwide distribution
Stop using Cipla Lanreotide Injection
Cipla USA is recalling certain pre-filled syringes of Lanreotide Injection 120 mg because they may contain particulate matter (small particles) in the solution. The affected syringes have specific lot numbers and expiration dates between October 2026 and March 2027. No injuries have been reported so far.
- Check if you have Lanreotide Injection with one of the recalled lot numbers listed in the FDA notice.
- Do not use the affected syringes.
- Contact your pharmacy or healthcare provider for a replacement or alternative medication.
- Keep the syringe and lot number information when you contact your provider.
Hazard
Presence of Particulate Matter.
Sold states
Nationwide in the USA
Affected count
15,221 syringes
Manufactured in
10 Independence Blvd, Warren, NJ, United States
Products
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0290-2026More 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 assurance defect
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility concerns
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