SUN PHARMACEUTICAL INDUSTRIES INC recalls Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals,
Sun Pharmaceutical recalls Ganire: 250 mcg/0.5 mL sterile prefilled syringes with failed impurities/degradation specs. Rx only. Check NDC 55566-1000-1 and lot numbers JKU1212A-JKU3314A.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company & request your remedy
What happened, in plain English
Sun Pharmaceutical is recalling Ganirelix Acetate Injection syringes due to potential impurities or degradation. This could affect patients using the medication for fertility treatments. The recall is for specific lot numbers and expiration dates. Read more at govinfonow.com/recall/36304-sun-pharmaceutical-ganirelix-acetate-injection-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36304-sun-pharmaceutical-ganirelix-acetate-injection-recall-failed-impurities-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0320-2021
Cite this page
“Sun Pharmaceutical Ganirelix Acetate Injection Recall: Failed Impurities Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36304-sun-pharmaceutical-ganirelix-acetate-injection-recall-failed-impurities-risk. Based on FDA recall #D-0320-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0320-2021%22&limit=1).
Why it’s dangerous
The product failed impurities or degradation specifications, which could lead to unsafe medication. This means the injection might contain harmful substances or break down in a way that affects safety.
Who’s affected
Patients prescribed Ganirelix Acetate Injection for fertility treatments in the U.S. and India. Those with the specific lot numbers and expiration dates listed are most at risk.
How to tell if you have this one
Check the product label for NDC 55566-1000-1 and lot numbers JKU1212A through JKU3314A. The syringes are for prescription use only and expire by March 2021 or August 2021.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 55566-1000-1 and lot numbers JKU1212A to JKU3314A on the syringe label.
Questions people ask
Is this product safe to use?
The recall states the product failed impurities/degradation specifications, so it may not be safe. Do not use the product until you confirm it's not recalled.
What should I do if I have this product?
Check the product label for the NDC and lot numbers. If it matches the recalled items, stop using it and contact your healthcare provider.
How can I get a replacement?
The recall record does not specify a replacement process. Contact Sun Pharmaceutical or your healthcare provider for guidance.
Contact Sun Pharmaceutical
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0320-2021 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0320-2021 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0320-2021 (March 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0320-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.