Lanreotide Acetate Injection
FDA Recall NDC 69097-890

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Lanreotide Acetate (NDC 69097-890). A significant event, classified as Class II, was initiated on Mar 13, 2026 by Cipla Usa Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure."

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0422-2026ONGOINGD-0290-2026ONGOING

March 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0422-2026
Class II Ongoing
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.
Initiated
Mar 13, 2026
Reported
Apr 15, 2026
Quantity
54,583 syringes

Recall Profile & Regulatory Data

Event ID
98575
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
69097-880-67Product
69097-890-67Product
69097-870-67Product

January 2026 Class II Recall: Presence of Particulate Matter.

Recall Number
D-0290-2026
Class II Ongoing
Reason for Recall
Presence of Particulate Matter.
Initiated
Jan 02, 2026
Reported
Jan 21, 2026
Quantity
15,221 syringes

Recall Profile & Regulatory Data

Event ID
98247
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Batch or Lot Expiration Information
Lot# Lot, expiry: 4301954IR1 , exp 31/10/2026 ; 4301994IR1 , exp 31/10/2026 ; 4301995IR1 , exp 31/10/2026 ; 4301996IR1 , exp 31/10/2026 ; 4400005IR1 , exp 30/11/2026 ; 4400006IR1 , exp 30/11/2026 ; 4400007IR1 , exp 30/11/2026 ; 4400124IR1 , exp 30/11/2026 ; 4400154IR1 , exp 30/11/2026 ; 4400155IR1 , exp 30/11/2026 ; 4400156IR1 , exp 30/11/2026 ; 4400373IR1 , exp 31/12/2026 ; 4400374IR1 , exp 31/12/2026 ; 4400375IR1 , exp 31/12/2026 ; 4400455IR1 , exp 31/1/2027 ; 4400456IR1 , exp 31/1/2027 ; 4400457IR1 , exp 31/1/2027 ; 4400544IR1 , exp 28/2/2027 ; 4400606IR1 , exp 28/2/2027 ; 4400607IR1 , exp 28/2/2027 ; 4400696IR1 , exp 28/2/2027 ; 4400697IR1 , exp 28/2/2027 ; 4400779IR1 , exp 28/2/2027 ; 4400780IR1 , exp 28/2/2027 ; 4400781IR1 , exp 28/2/2027 ; 4400844IR1 , exp 31/3/2027 ; 4400845IR1 , exp 31/3/2027 ; 4400849IR1 , exp 31/3/2027 ; 4400984IR1 , exp 31/3/2027 ; 4400985RIR , exp 31/3/2027 ; 4400986IR1 , exp 31/3/2027 ; 4401023IR1 , exp 31/3/2027
Affected Packages Involved in this Recall
69097-880-67Product
69097-890-67Product
69097-870-67Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.