The Recall Desk
HighFDA (Drugs)·D-0220-2026·Announced 2025-12-17

[pending] GANIRELIX ACETATE (GANIRELIX ACETATE)

Pending LLM rewrite. Source: FDA_DRUG D-0220-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

The recalled product

Product
GANIRELIX ACETATE (GANIRELIX ACETATE)
Brand
GANIRELIX ACETATE
Manufacturer
Lupin Pharmaceuticals Inc.

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

Distributed in 4 states:

  • FL
  • MA
  • MI
  • OH