Irinotecan Hydrochloride — manufacturers, supply & price · Pillstats

Who makes it4 active · 1 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

Labeler	Type	Packages	Status
Hikma Pharmaceuticals USA Inc.	unknown	3	SUPPLYING
NorthStar Rx LLC	unknown	2	SUPPLYING
Gland Pharma Limited	unknown	1	SUPPLYING
Xiromed, LLC.	unknown	1	SUPPLYING
Ingenus Pharmaceuticals, LLC	unknown	2	EXITED 2026

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

Feb 24, 2026
RESOLVEDShortage resolved: Irinotecan Hydrochloride Injection (Ingenus Pharmaceuticals LLC)
Irinotecan Hydrochloride Injection — reported in shortage by Ingenus Pharmaceuticals LLC. Therapeutic category: Oncology.
Feb 24, 2026
SHORTAGEDrug shortage: Irinotecan Hydrochloride Injection (Ingenus Pharmaceuticals LLC)
Irinotecan Hydrochloride Injection — reported in shortage by Ingenus Pharmaceuticals LLC. Therapeutic category: Oncology.
Jun 11, 2020
RECALLRecall (Class II): Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben …
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. — Recalling firm: Hikma Pharmaceuticals USA Inc. — Nationwide within the United States
Jun 11, 2020
RECALLRecall (Class II): Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben …
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. — Recalling firm: Hikma Pharmaceuticals USA Inc. — Nationwide within the United States
Jun 8, 2018
RECALLRecall (Class II): Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: …
Superpotent Drug: High out of specification assay value results for potency. — Recalling firm: Ingenus Pharmaceuticals Llc — Nationwide in the USA
Jun 8, 2018
RECALLRecall (Class II): Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: I…
Superpotent Drug: High out of specification assay value results for potency. — Recalling firm: Ingenus Pharmaceuticals Llc — Nationwide in the USA
Sep 23, 2013
RECALLRecall (Class II): Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured …
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim. — Recalling firm: West-Ward Pharmaceutical Corp. — Nationwide
Sep 23, 2013
RECALLRecall (Class II): Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured…
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim. — Recalling firm: West-Ward Pharmaceutical Corp. — Nationwide

Irinotecan Hydrochloride

Medicaid dispensing volumeSDUD · per quarter

Who makes it4 active · 1 exited

Regulatory & supply eventsFDA · US