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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cipla Lanreotide Injection Recalled for Lack of Assurance of Sterility

Agency Publication Date: April 3, 2026
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Summary

Cipla USA, Inc. is recalling 54,583 units of Lanreotide Injection (120 mg/0.5 mL) because a contract manufacturing site failed to follow proper visual inspection procedures, leading to a lack of assurance that the product is sterile. This recall involves pre-filled syringes sold at pharmacies nationwide. While no incidents or injuries have been reported to date, the lack of sterility in an injectable medication poses a significant health risk.

Risk

If an injectable drug is not sterile, it can introduce bacteria or other contaminants directly into the bloodstream or tissues, potentially causing serious infections or life-threatening systemic illness.

What You Should Do

  1. Check your medication to see if it is Lanreotide Injection, 120 mg/0.5 mL, and identify if it has NDC codes 69097-870-67 or 69097-906-67.
  2. Check the lot number and expiration date printed on the carton or syringe. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lanreotide Injection (120 mg/0.5 mL)by Cipla
Variants: 120 mg/0.5 mL, Pre-filled syringe, Safety needle
Lot Numbers (139):
4401666IR1 (Exp 8/31/2027)
4401703IR1 (Exp 9/30/2027)
4401703IR2 (EXP 9/30/2027)
4401704IR1 (Exp 9/30/2027)
4401705IR1 (Exp 9/30/2027)
4401706IR1 (Exp 9/30/2027)
4401720IR1 (Exp 9/30/2027)
4401721IR1 (Exp 9/30/2027)
4401733IR1 (Exp 9/30/2027)
4401770IR1 (Exp 9/30/2027)
4401777IR1 (Exp 9/30/2027)
4401788IR1 (Exp 10/31/2027)
4401804IR1 (Exp 10/31/2027)
4401805IR1 (Exp 10/31/2027)
4401824IR1 (Exp 10/31/2027)
4401860IR1 (Exp 10/31/2027)
4500019IR1 (Exp 11/30/2027)
4500035IR1 (Exp 11/30/2027)
4500036IR1 (Exp 11/30/2027)
4500078IR1 (Exp 11/30/2027)
4500079IR1 (Exp 11/30/2027)
4500102IR1 (Exp 12/31/2027)
4500119IR1 (Exp 12/31/2027)
4500120IR1 (Exp 12/31/2027)
4500121IR1 (Exp 12/31/2027)
4500268IR1 (Exp 1/31/2028)
4500269IR1 (Exp 1/31/2028)
4500272IR1 (Exp 1/31/2028)
4500314IR2 (EXP 1/31/2028)
4500314RIR (EXP 1/31/2028)
4500315IR1 (Exp 2/28/2028)
4500352IR1 (Exp 2/28/2028)
4500353IR1 (Exp 2/28/2028)
4500354IR1 (Exp 2/28/2028)
4500355IR1 (Exp 2/28/2028)
4500408IR1 (Exp 2/28/2028)
4500409IR1 (Exp 3/31/2028)
4500410IR1 (Exp 3/31/2028)
4500480IR1 (Exp 3/31/2028)
4500481IR1 (Exp 3/31/2028)
4500545IR1 (Exp 3/31/2028)
4500546IR1 (Exp 3/31/2028)
4500588IR1 (Exp 4/30/2028)
4500589IR1 (Exp 4/30/2028)
4500635IR1 (Exp 4/30/2028)
4500636IR1 (Exp 4/30/2028)
4500687IR1 (Exp 4/30/2028)
4500688IR1 (Exp 4/30/2028)
4500758IR1 (Exp 4/30/2028)
4500759IR1 (Exp 5/31/2028)
NDC:
69097-870-67
69097-906-67

Manufactured by Pharmathen International, S.A., Rodopi, Greece.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98575
Status: Active
Manufacturer: Cipla USA, Inc.
Sold By: Pharmacies
Manufactured In: Greece
Units Affected: 54,583 syringes
Distributed To: Nationwide
Agency Last Updated: April 9, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.