Lanreotide Injection recall
FDA recall D-0290-2026 · initiated Jan 2, 2026
Cipla USA, Inc. recalled Lanreotide Injection in Jan 2026 — an FDA Class II recall (D-0290-2026) because Presence of Particulate Matter.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 15,221 syringes
Details
- 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
- Recalling company
- Cipla Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 2, 2026
- FDA report date
- Jan 21, 2026
Frequently asked
- Was Lanreotide Injection recalled?
- Cipla USA, Inc. recalled Lanreotide Injection in Jan 2026 — an FDA Class II recall (D-0290-2026) because Presence of Particulate Matter. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lanreotide Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0290-2026 was: Presence of Particulate Matter.
- Is a recalled Lanreotide Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lanreotide Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot, expiry: 4301954IR1 , exp 31/10/2026 ; 4301994IR1 , exp 31/10/2026 ; 4301995IR1 , exp 31/10/2026 ; 4301996IR1 , exp 31/10/2026 ; 4400005IR1 , exp 30/11/2026 ; 4400006IR1 , exp 30/11/2026 ; 4400007IR1 , exp 30/11/2026 ; 4400124IR1 , exp 30/11/2026 ; 4400154IR1 , exp 30/11/2026 ; 4400155IR1 , exp 30/11/2026 ; 4400156…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0290-2026.