Moderate riskFDA DrugApr 15, 2026Class II

Cipla Lanreotide Injection 120 mg recalled for sterility assurance defect

Cipla USA is recalling specific lots of Lanreotide Injection (120 mg) because the manufacturer did not follow proper visual inspection procedures during production. This means the medication may not meet sterility standards and could potentially be contaminated.

From the FDA notice · Read the official notice ↗ · All Cipla recalls

What to do

Check if you have Lanreotide Injection with one of the recalled lot numbers listed on the FDA website or your pharmacy receipt.
Do not use recalled doses. Contact your doctor or pharmacist immediately for instructions on what to do.
If you have already used this medication, call your doctor to discuss any health concerns.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 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
Sold in: Nationwide
Made for: Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Illnesses reported: None reported
Manufactured in: 10 Independence Blvd, Warren, NJ, United States
Classification: Class II
Recall number: D-0423-2026

In the FDA's words

Description: 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 Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. 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; Distribution: Nationwide in the USA
Hazard: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

2 products in this recall

Cipla lanreotide injection recalled for sterility assurance concern

Cipla is recalling two versions of its lanreotide injection, 120 mg/0.5 mL pre-filled syringes, sold nationwide. The recall was prompted by an FDA observation at the contract manufacturing site about visual inspection procedures, so the product cannot be assured to be sterile. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen Internati…
D-0422-2026 · 54,583 syringes
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, G… (this page)
D-0423-2026