Reported Apr 15, 2026 · Ongoing

Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only,…

Cipla USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cipla USA, Inc. · 10 Independence Blvd · Warren, NJ · 07059-2730

Is this the product you have?

  • Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only
  • Manufactured byPharmathen International, S.A., Rodopi, Greece
  • Manufactured forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
  • NDC69097-870-67
Lot codes and dates
  • Lot
  • expiry

    128 of 128 codes

    • 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
Amount recalled
54,583 syringes

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.