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lanreotide acetatedrugHigh PriorityActive

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

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 was recalled because lack of assurance of sterility: due to an fda observation at the contract manufacturing site for deficiencies in their visual inspection procedure.. If you have this product, stop using it until you verify your lot or model details.

By RecallRadar Editorial Team

Sourced from FDA. Last verified April 20, 2026.

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Key facts

Date announced
April 15, 2026
Source agency
FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

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 was recalled because lack of assurance of sterility: due to an fda observation at the contract manufacturing site for deficiencies in their visual inspection procedure.. If you have this product, stop using it until you verify your lot or model details.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

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

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Lanreotide acetate
Category
drug
Source agency
FDA
Announced
April 15, 2026
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot, expiry: 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, Exp. 2/28/2027; 4500313IR1, Exp. 3/31/2027; 4500350IR1, Exp. 3/31/2027; 4500351IR1, Exp. 3/31/2027; 4500383IR1, Exp. 3/31/2027; 4500404IR1, Exp. 3/31/2027; 4500436RI1, Exp. 3/31/2027; 4500482IR1, Exp. 4/30/2027; 4500543IR1, Exp. 4/30/2027; 4500544IR1, Exp. 4/30/2027; 4500586IR1, Exp. 5/31/2027; 4500587IR1, Exp. 5/31/2027; 4500633IR1, Exp. 5/31/2027; 4500634IR1, Exp. 5/31/2027; 4500686IR1, Exp. 5/31/2027; 4500695IR1, Exp. 5/31/2027; 4500696IR1, Exp. 5/31/2027; 4500756IR1, Exp. 6/30/2027; 4500757IR1, Exp. 6/30/2027; 4500790IR1, Exp. 6/30/2027; 4500820IR1, Exp. 6/30/2027; 4500843IR1, Exp. 6/30/2027; 4500845IR1, Exp. 6/30/2027; 4500854IR1, Exp. 6/30/2027; 4500898IR1, Exp. 6/30/2027; 4500899IR1, Exp. 6/30/2027; 4500900IR1, Exp. 7/31/2027; 4500941IR1, Exp. 6/30/2027; 4500942IR1, Exp. 6/30/2027; 4500954IR1, Exp. 6/30/2027; 4500955IR1, Exp. 8/31/2027; 4500956IR1, Exp. 8/31/2027; 4500960IR1, Exp. 7/31/2027; 4501104IR1, Exp. 8/31/2027; 4501105IR1, Exp. 8/31/2027; 4501107IR1, Exp. 8/31/2027; 4501163IR1, Exp. 8/31/2027; 4501168IR1, Exp. 8/31/2027; 4501169IR1, Exp. 8/31/2027; 4501216IR1, Exp. 8/31/2027; 4501280IR1, Exp. 9/30/2027; 4501493IR1, Exp. 9/30/2027; 4501381IR1, Exp. 9/30/2027; 4501279IR1, Exp. 9/30/2027; 4501380IR1, Exp. 9/30/2027;

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1Stop using the affected product until you verify whether your item is impacted.
  2. 2Check the official recall notice and match your model, lot, or serial details.
  3. 3Follow the official instructions for repair, replacement, refund, or disposal.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
April 15, 2026
Last reviewed by RecallRadar
April 20, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Lot, expiry: 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, Exp. 2/28/2027; 4500313IR1, Exp. 3/31/2027; 4500350IR1, Exp. 3/31/2027; 4500351IR1, Exp. 3/31/2027; 4500383IR1, Exp. 3/31/2027; 4500404IR1, Exp. 3/31/2027; 4500436RI1, Exp. 3/31/2027; 4500482IR1, Exp. 4/30/2027; 4500543IR1, Exp. 4/30/2027; 4500544IR1, Exp. 4/30/2027; 4500586IR1, Exp. 5/31/2027; 4500587IR1, Exp. 5/31/2027; 4500633IR1, Exp. 5/31/2027; 4500634IR1, Exp. 5/31/2027; 4500686IR1, Exp. 5/31/2027; 4500695IR1, Exp. 5/31/2027; 4500696IR1, Exp. 5/31/2027; 4500756IR1, Exp. 6/30/2027; 4500757IR1, Exp. 6/30/2027; 4500790IR1, Exp. 6/30/2027; 4500820IR1, Exp. 6/30/2027; 4500843IR1, Exp. 6/30/2027; 4500845IR1, Exp. 6/30/2027; 4500854IR1, Exp. 6/30/2027; 4500898IR1, Exp. 6/30/2027; 4500899IR1, Exp. 6/30/2027; 4500900IR1, Exp. 7/31/2027; 4500941IR1, Exp. 6/30/2027; 4500942IR1, Exp. 6/30/2027; 4500954IR1, Exp. 6/30/2027; 4500955IR1, Exp. 8/31/2027; 4500956IR1, Exp. 8/31/2027; 4500960IR1, Exp. 7/31/2027; 4501104IR1, Exp. 8/31/2027; 4501105IR1, Exp. 8/31/2027; 4501107IR1, Exp. 8/31/2027; 4501163IR1, Exp. 8/31/2027; 4501168IR1, Exp. 8/31/2027; 4501169IR1, Exp. 8/31/2027; 4501216IR1, Exp. 8/31/2027; 4501280IR1, Exp. 9/30/2027; 4501493IR1, Exp. 9/30/2027; 4501381IR1, Exp. 9/30/2027; 4501279IR1, Exp. 9/30/2027; 4501380IR1, Exp. 9/30/2027;.

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the lanreotide acetate recall page.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0423-2026&limit=1

Keep browsing with these internal hubs: lanreotide acetate recall hub and Food & Drug recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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