Irinotecan Hydrochloride recalls

Irinotecan Hydrochloride products have been recalled 6 times, most recently on 24 Jun 2020. The recalling company is usually West-Ward Pharmaceutical. The most common reason is potency & assay.

Total recalls6since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 24 Jun 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why irinotecan hydrochloride is recalled

Potency & Assay467%
Other Reasons233%

Companies

Product types

Injectable & IV Drugs6100%

By year

2020233%
2018233%
2013233%

All irinotecan hydrochloride recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2020Drug	CLASS II	Irinotecan HCL Injection, USP, 100mg/ vials recalledIrinotecan Hydrochloride	Hikma Pharmaceuticals USA	Other	Nationwide
24 Jun 2020Drug	CLASS II	Irinotecan HCL Injection, USP, 100mg/ vials recalledIrinotecan Hydrochloride	Hikma Pharmaceuticals USA	Other	Nationwide
11 Jul 2018Drug	CLASS II	Irinotecan Hydrochloride Injection, USP, 40 mg/ (20 mg/mL) recalledIrinotecan Hydrochloride	Ingenus Pharmaceuticals	Potency & Assay	Nationwide
11 Jul 2018Drug	CLASS II	Irinotecan Hydrochloride Injection, USP, 100 mg/ (20 mg/mL) recalledIrinotecan Hydrochloride	Ingenus Pharmaceuticals	Potency & Assay	Nationwide
13 Nov 2013Drug	CLASS II	Irinotecan Hydrochloride Injection, 40 mg/ (20 mg/mL) recalledIrinotecan Hydrochloride	West-Ward Pharmaceutical	Potency & Assay	Nationwide
13 Nov 2013Drug	CLASS II	Irinotecan Hydrochloride Injection, 100 mg/ (20 mg/mL) recalledIrinotecan Hydrochloride	West-Ward Pharmaceutical	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.