Lower risk Drug recall · FDA · Published June 11, 2020

Hikma Irinotecan HCL Injection Recall: Crimp Defect Risk

Hikma Pharmaceuticals recalls Irinotecan HCL injection vials due to crimp defect causing flip-cap removal issues. Affected lots expire 08/2021 or 09/2021.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1308-2020Drug Hikma Pharmaceuticals ›

Lower-risk recall

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

Take action

Contact the company

Recalling firmHikma Pharmaceuticals USA Inc.2 Esterbrook Ln · Cherry Hill, NJ 08003-4002

✎ GovInfoNow plain-language explainer

Hikma Pharmaceuticals is recalling Irinotecan HCL injection vials that may have a crimp defect. This defect can cause problems when removing the flip-cap during use, potentially leading to injury. Read more at govinfonow.com/recall/37054-hikma-irinotecan-hcl-injection-recall-crimp-defect-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37054-hikma-irinotecan-hcl-injection-recall-crimp-defect-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1308-2020

Cite this page

“Hikma Irinotecan HCL Injection Recall: Crimp Defect Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37054-hikma-irinotecan-hcl-injection-recall-crimp-defect-risk. Based on FDA recall #D-1308-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1308-2020%22&limit=1).

The FDA announced on June 11, 2020, that Hikma Pharmaceuticals USA Inc. is recalling Irinotecan HCL Injection, USP due to a defective container. The hazard involves a crimp defect in the flip-cap during use.

How to tell if you have it

Brand: Hikma Pharmaceuticals
Product: Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials
NDC: 0143-9701-01
Lot codes: AC0231, AC0235 (exp. 08/2021); AC0237 (exp. 09/2021)
Quantity: 82,426 vials

The hazard

Customer complaints were received regarding a crimp defect while removing the flip-cap during use of the vials.

Context

GovInfoNow's records show Hikma Pharmaceuticals USA INC has 14 other recalls on record since December 17, 2019. Other recent recalls of similar products include Hikma Ramipril Capsules (August 24, 2026), Hikma Alendronate Sodium Oral Solution (April 7, 2026), and Hikma Lorazepam Injection (July 22, 2025). Other recent recalls of similar products include Asclemed Lidocaine HCl Injection (June 8, 2026), American Regent Papaverine HCl Injection (July 24, 2026), and Lupin Liraglutide 18mg/3mL Injection (April 24, 2026).

How to tell if you have this one

Check for vials with lot numbers AC0231, AC0235, or AC0237 that expire by 08/2021 or 09/2021. These vials were manufactured by Thymoorgan Pharmazie GmbH in Germany and distributed by West-Word Pharmaceutical Corp. in the US.

Brand
Hikma Pharmaceuticals
Category
Drug

FDA recall event · 2 products

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 within the United States

Recall number	Product, codes & lots	Quantity	NDC
D-1308-2020	Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01; Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021	82,426 vials	0143-9702-01, 0143-9701-01
D-1309-2020	Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01; Lot #:AC0231A, exp. date 08/2021	17,998 vials	0143-9583-01

Based on the official FDA remedy

What to do — step by step

Check Vial Lot Number
Look for lot numbers AC0231, AC0235, or AC0237 on the vial label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Jun 11, 2020Firm started the recall
Jun 12, 2020FDA classified it Class II
Jun 24, 2020Published in FDA’s Enforcement Report
Jun 10, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37054-hikma-irinotecan-hcl-injection-recall-crimp-defect-risk">Hikma Irinotecan HCL Injection Recall: Crimp Defect Risk (GovInfoNow)</a>

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-1308-2020 (June 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1308-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.