Quick Facts at a Glance
- Recall Date
- March 13, 2026
- Hazard Level
- HIGH
- Brands
- LANREOTIDE ACETATE, Cipla USA Inc.
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- PREGNANT, GENERAL, ELDERLY
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 Injection (pre-filled syringe)
- Model numbers
- Lot, expiry: 4401699IR1, Exp. 5/31/2026, 4401699IR2, Exp. 5/31/2026, 4401700IR1, Exp. 5/31/2026, 4401701IR1 +12 more
- UPC codes
- 69097-906, 69097-907, 69097-908, 69097-907-67, 69097-908-67, 69097-906-67
- Sizes
- 120 mg/0.5 mL
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 13, 2026
Reported by FDA DRUG
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Lanreotide acetate is used to treat acromegaly and neuroendocrine tumors. It is administered via subcutaneous injection.
Why This Is Dangerous
Sterility issues can lead to bacterial contamination or infection at the injection site or systemically.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate stop-use instructions; potential infection risk requires medical consultation.
Practical Guidance
How to identify if yours is affected
- Check NDC 69097-906-67 on the box and syringe label.
- Review lot numbers listed in recall materials.
- Check expiry date on each lot (5/31/2026).
Where to find product info
FDA enforcement report D-0423-2026 and Cipla recall communications.
What timeline to expect
Recall processing timelines vary; expect formal notification by letter.
If the manufacturer is unresponsive
- Document all contact attempts.
- Escalate to Cipla customer service and your healthcare provider.
- File a report with the FDA if necessary.
How to prevent similar issues
- Verify sterility for all injectable medications when receiving from a provider.
- Ensure supplier is legitimate and recalls are acknowledged before administration.
Documentation advice
Keep recall letter, packaging, lot numbers, and any medical records related to administration.
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Product Details
Lanreotide Injection, 120 mg/0.5 mL. Box contains 1 pre-filled syringe. 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 69097-906-67. Expiry dates and lot numbers vary by unit.
Reported Incidents
No incidents or injuries are described in the provided document. The recall status is ACTIVE with HIGH hazard level.
Key Facts
- Multiple Lot numbers with expiry 5/31/2026
- Exp 5/31/2026 for listed lots
- 4401699IR1 to 4401732IR1 lot series
- Manufactured for Cipla USA, Warren NJ
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Safety Guide
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