FDA Recall D-0290-2026
Cipla USA, Inc. · Warren, NJ
Class II Ongoing 132 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
Presence of Particulate Matter.
Recall record
- Recall number
D-0290-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Recall initiated
- 2026-01-02
- Classified by FDA Center
- 2026-01-15
- FDA published
- 2026-01-21
- Recalling firm
- Cipla USA, Inc.
- Firm location
- Warren, NJ
Drug identification
- Brand name(s)
- LANREOTIDE ACETATE
- Generic name(s)
- LANREOTIDE ACETATE
- Manufacturer(s)
- Cipla USA Inc.
- NDC(s)
69097-870, 69097-880, 69097-890- Route(s)
- SUBCUTANEOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.