Cipla USA Lanreotide Injection Class II Recall - Sterility Issues
Summary
FDA classified Cipla USA's voluntary recall of Lanreotide Injection (120 mg/0.5 mL) as Class II due to lack of sterility assurance. The recall was initiated after FDA observations at the contract manufacturing site (Pharmathen International, S.A., Greece) identified deficiencies in their visual inspection procedure. The recall covers 69 lot numbers distributed nationwide in the USA with expiration dates through August 2027.
What changed
FDA classified Cipla USA's voluntary recall of Lanreotide Injection as Class II due to lack of sterility assurance stemming from deficiencies in the visual inspection procedure at the contract manufacturing site. The recall encompasses 69 lot numbers of the 120 mg/0.5 mL strength, distributed nationwide in the USA, with expiration dates ranging from May 2026 through August 2027.
Pharmaceutical manufacturers producing sterile injectable products should review their visual inspection procedures and quality control systems to ensure compliance with FDA manufacturing standards. Healthcare providers and distributors should verify their inventory against the affected lot numbers and remove any recalled Lanreotide Injection from use.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Cipla USA, Inc.
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0423-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
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...
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.
Affected Lot Numbers / Codes
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;
Firm Notification Method
Letter
Distribution
Nationwide in the USA
Initiated
20260313
FDA Classified
20260403
Product Registration
Brand: LANREOTIDE ACETATE
Manufacturer: Cipla USA Inc.
Application: ANDA217193
NDC: 69097-906, 69097-907, 69097-908
Drug Label Context (from openFDA)
The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.
Indications & Usage
1 INDICATIONS AND USAGE Lanreotide Injection is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ( 1....
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ): For deep subcutaneous injection only. Intended for administration by a healthcare provider. Administer in the superior external quadrant of the buttock. Alternate injection sites. Recommended Dosage ( 2.1 ) Acromegaly: 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels. See full prescribing information for titration regimen. GEP-NETs: 120 mg every 4 weeks. Carcinoid Syndrome: 120 mg every 4 weeks. If patients are already being treated with Lanreotide Injection for GEP-NET, do not administer an additional do...
Contraindications
4 CONTRAINDICATIONS Lanreotide Injection is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide [see Adverse Reactions ( 6.3 )]. Hypersensitivity to lanreotide. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions to Lanreotide Injection are discussed in greater detail in other sections of the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Hypoglycemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Abnormalities [see Warnings and Precautions ( 5.3 )] Thyroid Function Abnormalities [see Warnings and Precautions ( 5.4 )] Steatorrhea and Malabsorption of Dietary Fats [see Warni...
Drug Interactions
7 DRUG INTERACTIONS Cyclosporine: Lanreotide Injection may decrease the absorption of cyclosporine. Dosage adjustment of cyclosporine may be needed. ( 7.2 ) Bromocriptine: Lanreotide Injection may increase the absorption of bromocriptine. ( 7.3 ) Bradycardia-Inducing Drugs (e.g., beta-blockers): Lanreotide Injection may decrease heart rate. Dosage adjustment of the coadministered drug may be necessary. ( 7.3 ) 7.1 Insulin and Oral Hypoglycemic Drugs Lanreotide, like somatostatin and other som...
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Lanreotide Injection is supplied in strengths of 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL as a white to pale yellow, semi-solid formulation in a single, sterile, prefilled, ready-to-use, polypropylene syringe (fitted with an automatic needle guard) fitted with a 20 mm needle covered by a sheath. Each prefilled syringe is sealed in a laminated pouch and ...
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