Cipla USA, Inc.: Drug Recall

Recall #D-0290-2026 · 01/02/2026

Class II: Risk

Recall Details

Recall Number: D-0290-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Cipla USA, Inc.
Status: Ongoing
Date Initiated: 01/02/2026
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15,221 syringes

Reason for Recall

Presence of Particulate Matter.

Product Description

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Cipla USA, Inc.

Class III: Low Risk 12/22/2025

Failed PH Specifications
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 10/24/2025

Failed stability specifications: Out of specification for hardness test

View all recalls by Cipla USA, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.