Class II Recall

Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only,

Summary

The FDA issued a Class II for Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 sa by Cipla USA, Inc.. Reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure..

Details

Source

Drug Recall

External ID

D-0422-2026

Action Date

2026-04-15

Status

Ongoing

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

Lot/Code Info: 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;

Quantity Affected: 54,583 syringes

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.

Distribution

Nationwide in the USA

Type: Voluntary: Firm initiated

Recall Initiated: 2026-03-13

Company

Cipla USA, Inc.

Warren, NJ

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 76 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cipla USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Cipla USA, Inc. have FDA actions?

Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0422-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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