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Unrated Drug recall · FDA · Published November 13, 2025

Lupin Ganirelix Acetate Injection Recall: Impurity Risk

Lupin Pharmaceuticals recalls Ganirelix Acetate injection due to impurities in the product. This may affect patients using the medication. Contact the manufacturer for details.

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

🇺🇸 FDA recall #D-0220-2026DrugLupin Pharmaceuticals ›
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Contact the company

Recalling firmLupin Pharmaceuticals Inc.5801 Pelican Bay Blvd, Suite 500 · Naples, FL 34108-2755
✎ GovInfoNow plain-language explainer

Lupin Pharmaceuticals is recalling Ganirelix Acetate injections because they contain impurities that could be harmful. This recall affects patients who have been prescribed this medication for fertility treatments. Read more at govinfonow.com/recall/31639-lupin-ganirelix-acetate-injection-recall-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31639-lupin-ganirelix-acetate-injection-recall-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0220-2026

Cite this page

“Lupin Ganirelix Acetate Injection Recall: Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31639-lupin-ganirelix-acetate-injection-recall-impurity-risk. Based on FDA recall #D-0220-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0220-2026%22&limit=1).

The FDA announced on 2025-11-13 that Lupin Pharmaceuticals Inc. is voluntarily recalling Ganirelix Acetate Injection due to failed impurity specifications. The recall affects 32,736 vials distributed in Florida, Massachusetts, Michigan, and Ohio.

How to tell if you have it

  • Brand: Lupin Pharmaceuticals
  • Product: Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only
  • NDC: 70748-274-01
  • Lot #: WB00006
  • Expiration: 12/31/2026
  • Quantity: 32,736 vials
  • Distribution: FL, MA, MI & OH

The hazard

The product failed to meet specifications for Ganirelix acetate acrylic acid adduct impurity. The FDA classifies this as a Class II recall.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since 2013-01-31. Recent similar recalls 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 Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (2025-12-30), Sagent Busulfan Injection Recall (2026-05-04), and Cipla Lanreotide Injection Recall (2026-03-13).

How to tell if you have this one

Check for the product name 'Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle' on the label. The product was manufactured by Lupin Pharmaceuticals and sold with NDC 70748-274-01.

  • Brand
    Lupin Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product name and NDC number 70748-274-01 on the label.

Where it went and when

Where it was distributed

Distributed in 4 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “FL, MA, MI & OH” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Massachusetts, Michigan, Ohio.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Nov 13, 202512. FDA classified it Class II: Dec 8, 202523. Published in FDA’s Enforcement Report: Dec 17, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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Other Lupin Pharmaceuticals recalls

Lupin Pharmaceuticals Inc. recalls Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL
August 3, 2026Lupin Pharmaceuticals Inc. recalls Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL
June 23, 2026Lupin Pharmaceuticals Inc. recalls prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC
June 4, 2026Lupin Pharmaceuticals Inc. recalls Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108,
April 24, 2026Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals,
November 5, 2025

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Keep exploring

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-0220-2026 (November 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0220-2026 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA