Reported Apr 15, 2026 · Ongoing

Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by:…

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, Single dose only, Rx Only
  • Manufactured byPharmathen International, S.A., Rodopi, Greece
  • Manufactured forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67
Lot codes and dates
  • Lot
  • expiry

    149 of 149 codes

    • 4401699IR1
    • Exp. 5/31/2026
    • 4401699IR2
    • Exp. 5/31/2026
    • 4401700IR1
    • Exp. 5/31/2026
    • 4401701IR1
    • Exp. 5/31/2026
    • 4401702IR1
    • Exp. 5/31/2026
    • 4401722IR1
    • Exp. 5/31/2026
    • 4401723IR1
    • Exp. 5/31/2026
    • 4401724IR1
    • Exp. 5/31/2026
    • 4401725IR1
    • Exp. 5/31/2026
    • 4401732IR1
    • Exp. 5/31/2026
    • 4401768IR1
    • Exp. 6/30/2026 4401769IR1
    • Exp. 11/30/2026
    • 4401787IR1
    • Exp. 11/30/2026
    • 4401815IR1
    • Exp. 11/30/2026
    • 4401816IR1
    • Exp. 11/30/2026
    • 4401834IR1
    • Exp. 11/30/2026
    • 4401835IR1
    • Exp. 11/30/2026
    • 4401846IR1
    • Exp. 11/30/2026
    • 4401851IR1
    • Exp. 11/30/2026
    • 4500017IR1
    • Exp. 12/31/2026
    • 4500031IR1
    • Exp. 12/31/2026
    • 4500032IR1
    • Exp. 12/31/2026
    • 4500033IR1
    • Exp. 12/31/2026
    • 4500076IR1
    • Exp. 1/31/2027
    • 4500117IR1
    • Exp. 2/28/2027
    • 4500118IR1
    • Exp. 2/28/2027
    • 4500173IR1
    • Exp. 4/31/2027
    • 4500270IR1
    • Exp. 2/28/2027
    • 4500271IR1
    • Exp. 2/28/2027
    • 4500273IR1
    • Exp. 2/28/2027
    • 4500312IR1

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, 5:06 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.