PillIrinotecan Hydrochloride
Irinotecan Hydrochloride
4 active makers
soon
soon
soon
soon
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
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, 2026RESOLVEDShortage resolved: Irinotecan Hydrochloride Injection (Ingenus Pharmaceuticals LLC)
Irinotecan Hydrochloride Injection — reported in shortage by Ingenus Pharmaceuticals LLC. Therapeutic category: Oncology.
- Feb 24, 2026SHORTAGEDrug shortage: Irinotecan Hydrochloride Injection (Ingenus Pharmaceuticals LLC)
Irinotecan Hydrochloride Injection — reported in shortage by Ingenus Pharmaceuticals LLC. Therapeutic category: Oncology.
- Jun 11, 2020RECALLRecall (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, 2020RECALLRecall (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, 2018RECALLRecall (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, 2018RECALLRecall (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, 2013RECALLRecall (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, 2013RECALLRecall (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