InvaGen Pharmaceuticals, Inc. recalls Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for:
InvaGen Pharmaceuticals recalls Decitabine injection (50mg/vial) due to impurities and water content issues. This medication, prescribed only, may pose risks if used improperly. Affected lots from India manufacturer.
Recall notice
Failed impurities/degradation specifications: Failure to water content and impurity
Contact the company & request your remedy
What happened, in plain English
InvaGen Pharmaceuticals is recalling Decitabine injection (50mg per vial) because it contains impurities and water content that could be harmful. This medication is prescription-only and may pose risks if used as intended. Read more at govinfonow.com/recall/40793-invagen-decitabine-injection-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/40793-invagen-decitabine-injection-recall-impurities-may-cause-harm · Updated October 7, 2026 · FDA enforcement record: FDA #D-0698-2018
Cite this page
“InvaGen Decitabine Injection Recall: Impurities May Cause Harm.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40793-invagen-decitabine-injection-recall-impurities-may-cause-harm. Based on FDA recall #D-0698-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0698-2018%22&limit=1).
Why it’s dangerous
The medication may contain impurities and water content that could be harmful when injected. This issue affects the safety of the drug and could lead to adverse reactions in patients.
Who’s affected
Prescription patients using Decitabine injection (50mg/vial) from specific lots manufactured by Cipla Ltd. in India. Patients with cancer treatments using this medication are most at risk.
How to tell if you have this one
Check for the product name 'Decitabine for Injection, 50mg per vial', prescription-only, and lots GE70493, GE70502, or GE70512 from the manufacturer Cipla Ltd. in India.
- Brand
InvaGen Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, dosage, and lot numbers to confirm if it is affected.
Questions people ask
Is this medication safe to use?
The recall indicates potential impurities and water content issues that could be harmful, so it is not safe to use as recalled.
What should I do if I have this medication?
The recall does not specify a remedy, so contact your healthcare provider for guidance.
How can I tell if I have the recalled product?
Check for the product name 'Decitabine for Injection, 50mg per vial', prescription-only, and lots GE70493, GE70502, or GE70512 from Cipla Ltd. in India.
Contact InvaGen Pharmaceuticals
We’ve drafted a message you can send InvaGen Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0698-2018 — InvaGen Pharmaceuticals InvaGen Pharmaceuticals Hello, I own a InvaGen Pharmaceuticals that is covered by recall D-0698-2018 from InvaGen Pharmaceuticals. 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.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-0698-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0698-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.