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
- GENERAL, PREGNANT, INFANTS
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
- Vial/Pre-filled Syringe Injection
- Model numbers
- Lot, expiry: 4401666IR1, Exp 8/31/2027, 4401703IR1, Exp 9/30/2027, 4401703IR2, EXP 9/30/2027, 4401704IR1 +12 more
- UPC codes
- 69097-870, 69097-880, 69097-890, 69097-880-67, 69097-890-67, 69097-870-67
- 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 a prescription somatostatin analog used to treat certain neuroendocrine tumors. The product is distributed in single-dose pre-filled syringes with a safety needle for healthcare administration.
Why This Is Dangerous
The sterility concern arises from visual inspection deficiencies at a contract manufacturing site. Contaminated injections could pose infection or other sterility-related risks to patients.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
No injuries reported yet. The recall could disrupt treatment for patients who rely on Lanreotide injections. Consumers should seek medical guidance and use alternatives if available.
Practical Guidance
How to identify if yours is affected
- Check NDC 69097-870-67 on product packaging.
- Check expiry dates on the box: Exp 8/31/2027 and Exp 9/30/2027.
Where to find product info
Recall notification letters from Cipla USA and FDA enforce reports linked above.
What timeline to expect
Refunds or replacements typically processed within weeks after compliance confirmation; CIPLA recall updates will specify timing.
If the manufacturer is unresponsive
- Contact FDA consumer complaint coordinators
- File a report with the manufacturer and seek consumer protection guidance
How to prevent similar issues
- Verify sterility assurances before receiving injectable medicines
- Trust only medications from licensed manufacturers
- Consult prescribers about alternatives if a sterility recall affects therapy
Documentation advice
Keep all recall notices, packaging, NDC labels, lot numbers, and correspondence with Cipla USA for records.
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Product Details
Brand: Lanreotide Acetate. Manufacturer: Pharmathen International S.A., Rodopi, Greece. For: Cipla USA, Inc., Warren, NJ. NDC: 69097-870-67. Distribution: Nationwide in the USA. Quantity: 54,583 syringes. Form: 120 mg*/0.5 mL pre-filled syringe with safety needle. Lot/Expiry: Several lots with Exp 8/31/2027 and Exp 9/30/2027 among listed codes.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Exp 8/31/2027 and Exp 9/30/2027 in listed lots
- FDA observation at contract manufacturing site for visual inspection deficiencies
- Single-dose, boxed with 1 syringe and 1 safety needle
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Safety Guide
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