FDA recall D-0422-2026

Cipla USA, Inc. · Class II · drug

Product

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

Reason for recall

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-03-13
Report date
2026-04-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0422-2026