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Food & drug recall · FDAMarch 13, 2026Serious

Cipla USA, Inc. — Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

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

The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Cipla USA, Inc.

The 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

Details

Recall date
March 13, 2026
Brand
Cipla USA, Inc.
Model, lot or SKU numbers
Lot, expiry: 4401699IR1, Exp. 5/31/20264401699IR2, Exp. 5/31/20264401700IR1, Exp. 5/31/20264401701IR1, Exp. 5/31/20264401702IR1, Exp. 5/31/20264401722IR1, Exp. 5/31/20264401723IR1, Exp. 5/31/20264401724IR1, Exp. 5/31/20264401725IR1, Exp. 5/31/20264401732IR1, Exp. 5/31/20264401768IR1, Exp. 6/30/2026 4401769IR1, Exp. 11/30/20264401787IR1, Exp. 11/30/20264401815IR1, Exp. 11/30/20264401816IR1, Exp. 11/30/20264401834IR1, Exp. 11/30/20264401835IR1, Exp. 11/30/20264401846IR1, Exp. 11/30/20264401851IR1, Exp. 11/30/20264500017IR1, Exp. 12/31/20264500031IR1, Exp. 12/31/20264500032IR1, Exp. 12/31/20264500033IR1, Exp. 12/31/20264500076IR1, Exp. 1/31/20274500117IR1, Exp. 2/28/2027
Where it was distributed

Nationwide in the USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “Cipla USA, Inc. — 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 Bouleva”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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