Ganirelix acetate injection recalled after failing an impurity specification
Lupin Pharmaceuticals is recalling 32,736 units of Ganirelix Acetate Injection after out of specification results for the ganirelix acetate acrylic acid adduct impurity.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an out of specification impurity result with no stated clinical consequence or reported harm.
Plain-English summary
Ganirelix Acetate Injection, 250 mcg/0.5mL, in single-dose sterile prefilled syringes with a 27 gauge by 1/2 inch needle, is being recalled. The prescription product is manufactured by Lupin Limited of Nagpur, India, for Lupin Pharmaceuticals, Inc. of Naples, Florida.
The recall follows failed impurities and degradation specifications: out of specification results for the ganirelix acetate acrylic acid adduct impurity.
The record lists 32,736 units from lot WB00006, expiry 12/31/2026. Distribution covered Florida, Massachusetts, Michigan and Ohio. The FDA has classified the action as Class II.
The record describes a specification failure rather than a reported patient harm. Patients should not stop using a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific lot is affected and arrange a replacement.
The recalled product
- Product
- GANIRELIX ACETATE (GANIRELIX ACETATE)
- Brand
- GANIRELIX ACETATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Fertility injectable
- Affected units
- 32,736
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: WB00006
- Exp 12/31/2026
UPCs (1)
- 0370748274019
Distribution
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