FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Cipla Lanreotide Injection 120 mg recalled for sterility concerns
OTHERNationwide distribution
Do not use Cipla Lanreotide Injection
Cipla USA is recalling specific lots of Lanreotide Injection 120 mg due to concerns about sterility. The FDA found deficiencies in the manufacturer's visual inspection procedures, which could mean some syringes may not be properly sterilized. No injuries have been reported so far.
- Check your medication: Look for lot numbers starting with 440, 450, or 4501 with expiration dates through August 2028
- Do not use the recalled syringes
- Contact your doctor or pharmacist for a replacement or alternative medication
- If you received a recalled lot, report it to the FDA MedWatch program or Cipla at 1-800-818-4555
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
Affected count
54,583 syringes
Manufactured in
10 Independence Blvd, Warren, NJ, United States
Products
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: 69097-870-67
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0422-2026More 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
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