CLASS II ONGOING Drug recall · Reported 17 Dec 2025 · FDA Enforcement Report
Ganirelix Acetate Injection, 250 mcg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Ganirelix Acetate Injection, 250 mcg/, Single-dose Sterile Prefilled Syringe by 1/2', distributed in Florida, Massachusetts, Michigan, Ohio. The recall was initiated on 13 Nov 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0220-2026
- FDA event ID
- 97990
- Recalling firm
- Lupin Pharmaceuticals, Naples, FL
- Brand
- Ganirelix Acetate
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Nov 2025
- FDA classified
- 8 Dec 2025
- Reported
- 17 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Nov 2025 | Recall initiated by company | |
| 8 Dec 2025 | Classified by FDA | +25 days |
| 17 Dec 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
Where it was distributed
FL, MA, MI & OH
Questions about this recall
Why was it recalled?
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Which lots are affected?
Lot #: WB00006, Exp 12/31/2026
Where was it sold?
FL, MA, MI & OH
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ganirelix recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fyremadel (ganirelix acetate) injection, 250 mcg recalledFyremadel | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Ganirelix Acetate Injection, 250 mcg/, Sterile Prefilled Syringe recalled | SUN Pharmaceutical Industries | Potency & Assay | NJ |