What was recalled and why?

Lupin Pharmaceuticals Inc. 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.. FDA's record states the reason for recall as: Presence of particulate matter: a white thread-like structure in the cartridge. The recall is logged under FDA recall number D-0541-2026 with a Class II classification.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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.) and recall number D-0541-2026, then follow Lupin Pharmaceuticals Inc.'s recall.

Has Lupin Pharmaceuticals Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Lupin Pharmaceuticals Inc., including 4 recalls and 0 warning letters.

Recall Record: Class II Recall: LIRAGLUTIDE by Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. 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. on 2026-05-27. FDA classified this action as a Class II recall (recall number D-0541-2026). Reason for recall: Presence of particulate matter: a white thread-like structure in the cartridge. Recall status: Ongoing. This is a drug-category FDA recall record.

Key facts

Recalling firm	Lupin Pharmaceuticals Inc.
Manufacturer	Lupin Pharmaceuticals, Inc.
Brand name	LIRAGLUTIDE
Product description	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.
Classification	Class II
Recall number	D-0541-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Presence of particulate matter: a white thread-like structure in the cartridge

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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. -- and the recall number D-0541-2026. If it matches, stop using or distributing it and contact Lupin Pharmaceuticals Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Lupin Pharmaceuticals Inc. and the affected product is described in FDA's record 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.. FDA's stated reason for the recall is: Presence of particulate matter: a white thread-like structure in the cartridge. The recall is tracked under FDA recall number D-0541-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

Lupin Pharmaceuticals Inc.’s FDA history

Argus HQ has recorded 4 total FDA actions tied to Lupin Pharmaceuticals Inc.: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?: Lupin Pharmaceuticals Inc. 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.. FDA's record states the reason for recall as: Presence of particulate matter: a white thread-like structure in the cartridge. The recall is logged under FDA recall number D-0541-2026 with a Class II classification.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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.) and recall number D-0541-2026, then follow Lupin Pharmaceuticals Inc.'s recall.
Has Lupin Pharmaceuticals Inc. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Lupin Pharmaceuticals Inc., including 4 recalls and 0 warning letters.

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Full FDA history for Lupin Pharmaceuticals Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: LIRAGLUTIDE by Lupin Pharmaceuticals Inc.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-lupin-pharmaceuticals-inc-d-0541-2026

MLA

"Recall Record: Class II Recall: LIRAGLUTIDE by Lupin Pharmaceuticals Inc.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-lupin-pharmaceuticals-inc-d-0541-2026.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: LIRAGLUTIDE by Lupin Pharmaceuticals Inc.." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/recall/fda-recall-lupin-pharmaceuticals-inc-d-0541-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_lupin_pharmaceuticals_inc_d_0541_2026_2026,
  title = {Recall Record: Class II Recall: LIRAGLUTIDE by Lupin Pharmaceuticals Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/fda-recall-lupin-pharmaceuticals-inc-d-0541-2026},
  note = {Accessed: August 13, 2026}
}

Source: FDA.gov — Recalls ↗