Use caution Drug recall · FDA · Published April 24, 2026

Lupin Liraglutide 18mg/3mL Injection Recall: Particulate Matter Hazard

Lupin Pharmaceuticals recalls Liraglutide injection with white thread-like particles that could cause injection site reactions. Affected lots expire through 2027. Stop using and contact for replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0541-2026Drug Lupin ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmLupin Pharmaceuticals Inc.5801 Pelican Bay Blvd Ste 500 · Naples, FL 34108-2734

✎ GovInfoNow plain-language explainer

Lupin Pharmaceuticals is recalling Liraglutide injection products that contain a white thread-like structure in the cartridge. This particulate matter could cause injection site reactions or other issues if injected. Affected products were sold in the U.S. and Canada through specific lot numbers. Read more at govinfonow.com/recall/31332-lupin-liraglutide-18mg-3ml-injection-recall-particulate-matter-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/31332-lupin-liraglutide-18mg-3ml-injection-recall-particulate-matter-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #D-0541-2026

Cite this page

“Lupin Liraglutide 18mg/3mL Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31332-lupin-liraglutide-18mg-3ml-injection-recall-particulate-matter-hazard. Based on FDA recall #D-0541-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0541-2026%22&limit=1).

Lupin Pharmaceuticals Inc. recalled Liraglutide Injection pens nationwide on April 24, 2026, after the FDA announced the Class II voluntary recall due to particulate matter in the cartridges. The Food and Drug Administration issued the recall notice for the drug product.

How to tell if you have it

Brand: Lupin
Product: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only
NDC 70748-346-02 (2 Pens)
NDC 70748-346-03 (3 Pens)
Lots: WB00097, WB00094, WB00088 (Expires Jul. 2027); WB00103 (Expires Oct. 2027); WC00016 (Expires Dec. 2027); WB00098, WB00092, WB00093 (Expires Jul. 2027); WB00104, WB00106, WB00105 (Expires Oct. 2027)
Quantity: 217,621 pen injectors

The hazard

The recall addresses the presence of particulate matter, specifically a white thread-like structure in the cartridge. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since 2013-01-31. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (2026-08-03), Lupin Glucagon Emergency Kit Recall (2026-06-23), and Lupin prednisolone acetate ophthalmic suspension recall (2026-06-04). Other recent recalls of similar products include Cipla Lanreotide Injection Recall (2026-01-02), American Regent Tralement injection recall (2026-07-24), and American Regent Nitroglycerin Injection Recall (2026-07-24).

How to tell if you have this one

Check the product label for the lot numbers: WB00097, WB00094, WB00088 (expiring Jul 2027) or WB00098, WB00092, WB00093 (expiring Jul 2027). The product comes in 2-pen or 3-pen packages with NDC codes 70748-346-02 or 70748-346-03.

Brand
Lupin
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Product
Immediately stop using the recalled Liraglutide injection if you have the affected lot numbers.
Contact Manufacturer
Contact Lupin Pharmaceuticals for a replacement or refund for the recalled products.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 33 days after the firm started it.

Apr 24, 2026Firm started the recall
May 19, 2026FDA classified it Class II
May 27, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Lupin recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31332-lupin-liraglutide-18mg-3ml-injection-recall-particulate-matter-hazard">Lupin Liraglutide 18mg/3mL Injection Recall: Particulate Matter Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0541-2026 (April 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0541-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.