The Recall Registry
Recall data checked 6 hours ago

Home Prescription medicine Cipla USA, Inc. — Lanreotide Injection, 120…

Food & drug recall · FDAMarch 13, 2026Serious

Cipla USA, Inc. — Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, 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 seriousFDA 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 and 1 safety needle, 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: 69097-870-67

Details

Units affected
54,583 syringes
Recall date
March 13, 2026
Brand
Cipla USA, Inc.
Model, lot or SKU numbers
Lot, expiry: 4401666IR1, Exp 8/31/20274401703IR1, Exp 9/30/20274401703IR2, EXP 9/30/20274401704IR1, Exp 9/30/20274401705IR1, Exp 9/30/20274401706IR1, Exp 9/30/20274401720IR1, Exp 9/30/20274401721IR1, Exp 9/30/20274401733IR1, Exp 9/30/20274401770IR1, Exp 9/30/20274401777IR1, Exp 9/30/20274401788IR1, Exp 10/31/20274401804IR1, Exp 10/31/20274401805IR1, Exp 10/31/20274401824IR1, Exp 10/31/20274401860IR1, Exp 10/31/20274500019IR1, Exp 11/30/20274500035IR1, Exp 11/30/20274500036IR1, Exp 11/30/20274500078IR1, Exp 11/30/20274500079IR1, Exp 11/30/20274500102IR1, Exp 12/31/20274500119IR1, Exp 12/31/20274500120IR1, Exp 12/31/2027
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 and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10

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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