Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only,
Fresenius Kabi recalls Ketorol: 60mg/2mL injection vials due to particulate matter found in reserve samples. This may cause serious injury if injected.
Use caution until it’s fixed
Presence of Particulate Matter - found in reserve sample vials at the firm.
Contact the company & request your remedy
What happened, in plain English
Fresenius Kabi is recalling Ketorolac injection vials that may contain particles. Using these vials could cause serious injury if injected. Read more at govinfonow.com/recall/36591-fresenius-kabi-ketorolac-injection-recall-particulate-matter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36591-fresenius-kabi-ketorolac-injection-recall-particulate-matter-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0184-2021
Cite this page
“Fresenius Kabi Ketorolac Injection Recall: Particulate Matter Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36591-fresenius-kabi-ketorolac-injection-recall-particulate-matter-risk. Based on FDA recall #D-0184-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0184-2021%22&limit=1).
Why it’s dangerous
Particulate matter found in some reserve samples can enter the bloodstream during injection, potentially causing serious injury or death.
Who’s affected
Prescription users of Ketorolac injection vials from Fresenius Kabi. Patients receiving this medication for pain or inflammation are most at risk.
How to tell if you have this one
Check for vials labeled 'Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL)' from Fresenius Kabi. The NDC code 63323-162-02 and batch number 6121125 are associated with this recall.
- Brand
Fresen: Kabi- Category
Drug
What to do — step by step
Check Vial Label
Look for the product name and NDC code on the vial to confirm it matches the recalled items.
Contact Healthcare Provider
If you have the recalled vial, inform your healthcare provider immediately to discuss next steps.
Questions people ask
Is this product safe to use?
The recall indicates particulate matter was found in reserve samples, so it is not safe to use without checking the recall status.
What should I do if I have the recalled vial?
Contact your healthcare provider to discuss whether you should stop using the vial and how to proceed.
How can I check if my vial is recalled?
Check the vial label for the product name and NDC code 63323-162-02, and batch number 6121125.
Contact Fresen: Kabi
We’ve drafted a message you can send Fresen: Kabi to request your refund or repair — edit it as you like.
Subject: Recall D-0184-2021 — Fresen: Kabi Fresen: Kabi Hello, I own a Fresen: Kabi that is covered by recall D-0184-2021 from Fresen: Kabi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0184-2021 (December 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0184-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.