Quick Facts at a Glance
- Recall Date
- January 2, 2026
- Hazard Level
- HIGH
- Brands
- LANREOTIDE ACETATE, Cipla USA Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- LANREOTIDE ACETATE, Cipla USA Inc.
- Product type
- Lanreotide Acetate Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe
- Model numbers
- 4301954IR1, 4301994IR1, 4301995IR1, 4301996IR1, 4400005IR1, 4400006IR1, 4400007IR1, 4400124IR1 +2 more
- UPC codes
- 69097-870, 69097-880, 69097-890, 69097-880-67, 69097-890-67, 69097-870-67
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 2, 2026
Reported by FDA DRUG
January 21, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Presence of Particulate Matter.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance
About This Product
Lanreotide Acetate Injection is a prescription medication delivered by subcutaneous injection. It is used to manage certain neuroendocrine conditions and tumors. The recall covers multiple lots distributed nationwide in the United States.
Why This Is Dangerous
Particulate matter in an injectable solution can cause local or systemic reactions and may pose health risks depending on the nature of the particulates and injection site.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Patients on Lanreotide injections may experience delays in treatment and must transition to alternative therapy as guided by a clinician. The recall creates a potential risk if particulates are injected.
Practical Guidance
How to identify if yours is affected
- Verify NDC 69097-870-67 on the vial label.
- Note expiry dates associated with each lot (e.g., 31/10/2026 or 30/11/2026).
Where to find product info
Recall details are on the FDA enforcement page linked in the notice and on Cipla USA communications.
What timeline to expect
Replacement or guidance timeline is not specified in the notice. Check with Cipla USA or FDA for updates.
If the manufacturer is unresponsive
- Escalate to FDA MedWatch if you experience adverse effects.
- Contact your healthcare provider for alternatives and document all communications.
How to prevent similar issues
- Regularly check recall notices for prescription medications you use.
- Verify lot numbers and expiry dates before administration.
- Maintain a current list of medications and their lot numbers for quick reference in recalls.
Documentation advice
Keep the recall notice, packaging, lot numbers, and any correspondence with the manufacturer or healthcare provider. Document adverse events with dates and symptoms.
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Product Details
Lanreotide Acetate Injection, 120 mg/0.5 mL. 0.5 mL per pre-filled syringe. For deep subcutaneous injection. NDC 69097-870-67. Sold nationwide in the USA. Manufactured for Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. Quantity: 15,221 syringes. Recall Date: 2026-01-02. Status: ACTIVE. Distribution: Nationwide in the USA.
Key Facts
- Manufacturer: Cipla USA, Inc.
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Safety Guide
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