Ganirelix Acetate Injection recall
FDA recall D-0220-2026 · initiated Nov 13, 2025
Lupin Pharmaceuticals Inc. recalled Ganirelix Acetate Injection in Nov 2025 — an FDA Class II recall (D-0220-2026) because Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 32736 vials
Details
- Product
- 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
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- FL, MA, MI & OH
- Initiated
- Nov 13, 2025
- FDA report date
- Dec 17, 2025
This recall is linked to a product we cover: Ganirelix Acetate →
Frequently asked
- Was Ganirelix Acetate Injection recalled?
- Lupin Pharmaceuticals Inc. recalled Ganirelix Acetate Injection in Nov 2025 — an FDA Class II recall (D-0220-2026) because Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ganirelix Acetate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0220-2026 was: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- Is a recalled Ganirelix Acetate Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ganirelix Acetate Injection are affected?
- Distributed: FL, MA, MI & OH. The recall covers these lots — Lot #: WB00006, Exp 12/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0220-2026.