CLASS II ONGOING Drug recall · Reported 15 Apr 2026 · FDA Enforcement Report

Lanreotide Injection, 120 mg* recalled by Cipla USA

Cipla USA is recalling Lanreotide Injection, 120 mg*/, Box contains 1 Pre-filled syringe and 1 safety needle, distributed nationwide in the US. The recall was initiated on 13 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1, Exp 10/31/2027; 4401805IR1, Exp 10/31/2027; 4401824IR1, Exp 10/31/2027; 4401860IR1, Exp 10/31/2027; 4500019IR1, Exp 11/30/2027; 4500035IR1, Exp 11/30/2027; 4500036IR1, Exp 11/30/2027; 4500078IR1, Exp 11/30/2027; 4500079IR1, Exp 11/30/2027; 4500102IR1, Exp 12/31/2027; 4500119IR1, Exp 12/31/2027; 4500120IR1, Exp 12/31/2027; 4500121IR1, Exp 12/31/2027; 4500268IR1, Exp 1/31/2028; 4500269IR1, Exp 1/31/2028; 4500272IR1, Exp 1/31/2028; 4500314IR2, EXP 1/31/2028; 4500314RIR, EXP 1/31/2028; 4500315IR1, Exp 2/28/2028; 4500352IR1, Exp 2/28/2028; 4500353IR1, Exp 2/28/2028; 4500354IR1, Exp 2/28/2028; 4500355IR1, Exp 2/28/2028; 4500408IR1, Exp 2/28/2028; 4500409IR1, Exp 3/31/2028; 4500410IR1, Exp 3/31/2028; 4500480IR1, Exp 3/31/2028; 4500481IR1, Exp 3/31/2028; 4500545IR1, Exp 3/31/2028; 4500546IR1, Exp 3/31/2028; 4500588IR1, Exp 4/30/2028; 4500589IR1, Exp 4/30/2028; 4500635IR1, Exp 4/30/2028; 4500636IR1, Exp 4/30/2028; 4500687IR1, Exp 4/30/2028; 4500688IR1, Exp 4/30/2028; 4500758IR1, Exp 4/30/2028; 4500759IR1, Exp 5/31/2028; 4500788IR1, Exp 5/31/2028; 4500789IR1, Exp 5/31/2028; 4500819IR1, Exp 5/31/2028; 4500846IR1, Exp 5/31/2028; 4500849IR1, Exp 6/30/2028; 4500850IR1, Exp 7/31/2028; 4500907IR1, Exp 7/31/2028; 4501108IR1, Exp 7/31/2028; 4501109IR1, Exp 7/31/2028; 4501110IR1, Exp 7/31/2028; 4501111IR1, Exp 7/31/2028; 4501166IR1, Exp 7/31/2028; 4501386IR1, Exp 8/31/2028; 4501387IR1, Exp 8/31/2028;

NDC69097-870, 69097-880, 69097-890

Quantity recalled54,583 syringes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0422-2026
FDA event ID: 98575
Recalling firm: Cipla USA, Warren, NJ
Brand: Lanreotide Acetate
Manufacturer: Cipla USA Inc.
Classification: Class II
Status: Ongoing
Recall initiated: 13 Mar 2026
FDA classified: 3 Apr 2026
Reported: 15 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

13 Mar 2026	Recall initiated by company
3 Apr 2026	Classified by FDA	+21 days
15 Apr 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1, Exp 10/31/2027; 4401805IR1, Exp 10/31/2027; 4401824IR1, Exp 10/31/2027; 4401860IR1, Exp 10/31/2027; 4500019IR1, Exp 11/30/2027; 4500035IR1, Exp 11/30/2027; 4500036IR1, Exp 11/30/2027; 4500078IR1, Exp 11/30/2027; 4500079IR1, Exp 11/30/2027; 4500102IR1, Exp 12/31/2027; 4500119IR1, Exp 12/31/2027; 4500120IR1, Exp 12/31/2027; 4500121IR1, Exp 12/31/2027; 4500268IR1, Exp 1/31/2028; 4500269IR1, Exp 1/31/2028; 4500272IR1, Exp 1/31/2028; 4500314IR2, EXP 1/31/2028; 4500314RIR, EXP 1/31/2028; 4500315IR1, Exp 2/28/2028; 4500352IR1, Exp 2/28/2028; 4500353IR1, Exp 2/28/2028; 4500354IR1, Exp 2/28/2028; 4500355IR1, Exp 2/28/2028; 4500408IR1, Exp 2/28/2028; 4500409IR1, Exp 3/31/2028; 4500410IR1, Exp 3/31/2028; 4500480IR1, Exp 3/31/2028; 4500481IR1, Exp 3/31/2028; 4500545IR1, Exp 3/31/2028; 4500546IR1, Exp 3/31/2028; 4500588IR1, Exp 4/30/2028; 4500589IR1, Exp 4/30/2028; 4500635IR1, Exp 4/30/2028; 4500636IR1, Exp 4/30/2028; 4500687IR1, Exp 4/30/2028; 4500688IR1, Exp 4/30/2028; 4500758IR1, Exp 4/30/2028; 4500759IR1, Exp 5/31/2028; 4500788IR1, Exp 5/31/2028; 4500789IR1, Exp 5/31/2028; 4500819IR1, Exp 5/31/2028; 4500846IR1, Exp 5/31/2028; 4500849IR1, Exp 6/30/2028; 4500850IR1, Exp 7/31/2028; 4500907IR1, Exp 7/31/2028; 4501108IR1, Exp 7/31/2028; 4501109IR1, Exp 7/31/2028; 4501110IR1, Exp 7/31/2028; 4501111IR1, Exp 7/31/2028; 4501166IR1, Exp 7/31/2028; 4501386IR1, Exp 8/31/2028; 4501387IR1, Exp 8/31/2028;

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98575

This product is part of a recall event; the main page for the event is Lanreotide Injection, 120 mg recalled by Cipla USA.

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026	CLASS II	Lanreotide Injection, 120 mg recalled by Cipla USALanreotide Acetate	Cipla USA	Sterility	Nationwide

More recalls from Cipla USA

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8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
22 Apr 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
22 Apr 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide

Other Lanreotide recalls

All 3

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	Lanreotide Injection, 120 mg recalled by Cipla USALanreotide Acetate	Cipla USA	Sterility	Nationwide
21 Jan 2026Drug	CLASS II	Lanreotide Injection, 120 mg/ per pre-filled syringe recalledLanreotide Acetate	Cipla USA	Particulate Matter	Nationwide