Ingenus Pharmaceuticals recalls Irinotecan injection due to potency issues
Ingenus Pharmaceuticals recalls specific lot numbers of Irinotecan Hydrochloride Injection due to high potency assay results. This may affect cancer treatment safety.
Lower-risk recall
Superpotent Drug: High out of specification assay value results for potency.
Contact the company
What happened, in plain English
Ingenus Pharmaceuticals is recalling certain lots of Irinotecan Hydrochloride Injection because the drug shows higher potency than specified. This could lead to unsafe treatment outcomes for patients using the medication. Read more at govinfonow.com/recall/40494-ingenus-pharmaceuticals-recalls-irinotecan-injection-due-to-potency-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/40494-ingenus-pharmaceuticals-recalls-irinotecan-injection-due-to-potency-issues · Updated October 7, 2026 · FDA enforcement record: FDA #D-0890-2018
Cite this page
“Ingenus Pharmaceuticals recalls Irinotecan injection due to potency issues.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40494-ingenus-pharmaceuticals-recalls-irinotecan-injection-due-to-potency-issues. Based on FDA recall #D-0890-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0890-2018%22&limit=1).
Why it’s dangerous
The drug has higher potency than intended, which could cause unexpected and severe side effects during cancer treatment. This is a quality issue in the manufacturing process.
Who’s affected
Patients prescribed this cancer treatment medication by a doctor. Those using the recalled lots are most at risk.
How to tell if you have this one
Check the product label for the lot numbers 17034-1, 17035-1, or 17036-1. The product is a single-dose vial for cancer treatment, manufactured by Ingenus Pharmaceuticals.
- Brand
Ingenus Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA- NDC
50742-401-02, 50742-402-05
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0890-2018 | Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.; Lot #: 17034-1, 17035-1, 17036-1; Exp. 08/19 | 34964 vials |
| D-0891-2018 | Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.; Lot #: 17034-2, 17035-2, 17036-2; Exp. 08/19 | 14089 vials |
What to do — step by step
Check Product Label
Look for lot numbers 17034-1, 17035-1, or 17036-1 on the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled product?
Contact your doctor or the manufacturer to discuss next steps, as the recall does not include a specific return or disposal instruction.
Similar recalls
Latest drug recalls
Keep exploring
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-0890-2018 (June 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0890-2018 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.