RecallRadar
ModerateReported May 27, 2026 (5 weeks ago)

Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only

Recalled by Lupin Pharmaceuticals Inc.

Product image for Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
Product image via DailyMed (National Library of Medicine). It may show general packaging and not the exact recalled lot — always confirm using the codes below.

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Lupin Pharmaceuticals Inc. has recalled Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on May 27, 2026 and was initiated on April 24, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, with approximately 217,621 pen injectors affected. The company behind the recall is Lupin Pharmaceuticals Inc., based in Naples, FL. The FDA describes the product as: “Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.”

Why was Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only recalled?

According to the FDA, the stated reason for the recall is: “Presence of particulate matter: a white thread-like structure in the cartridge.” In plain terms, this recall relates to a sterility or contamination concern.

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

What should you do?

If you think you may have bought Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, compare it against the product description and identifying codes (Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2…) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Lupin Pharmaceuticals Inc. or your local health authority.

About this recall

This recall was distributed in FL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Full recall details

Status
Ongoing
Date reported
May 27, 2026
Recall started
April 24, 2026
Distributed in
FL
What was recalled
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
Why it was recalled (as stated by the FDA)
Presence of particulate matter: a white thread-like structure in the cartridge
How to identify the affected product
Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027.
Amount recalled
217,621 pen injectors

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only recalled?+

According to the FDA: Presence of particulate matter: a white thread-like structure in the cartridge

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

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View the official FDA record

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0541-2026. Information last synced from the FDA on July 5, 2026.

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