Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL
Fresenius Kabi recalls Ketorolac injection vials due to particulate matter found in some samples. This may cause serious injury if injected. Check your vial's lot number and contact the company for details.
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 particulate matter. This could cause serious injury if injected into the body. Affected vials have a specific lot number and packaging. Read more at govinfonow.com/recall/36568-fresenius-kabi-ketorolac-injection-recall-particulate-matter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36568-fresenius-kabi-ketorolac-injection-recall-particulate-matter-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0245-2021
Cite this page
“Fresenius Kabi Ketorolac Injection Recall: Particulate Matter Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36568-fresenius-kabi-ketorolac-injection-recall-particulate-matter-risk. Based on FDA recall #D-0245-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0245-2021%22&limit=1).
Why it’s dangerous
Particulate matter in the vials can enter the bloodstream during injection, potentially causing serious injury or death. The hazard was found in reserve samples at the manufacturer.
Who’s affected
Patients prescribed Ketorolac injections by doctors who used the recalled vials. Those with medical conditions requiring injections are at higher risk.
How to tell if you have this one
Check for vials labeled 'Ketorolac Tromethamine Injection, USP, 30 mg per mL' with NDC 63323-162-00 or 63323-162-01. The lot number is 6121083 with an expiration date of February 2021.
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Check Vial Lot Number
Look for lot number 6121083 on the vial label. This is the specific batch affected by the particulate matter issue.
Contact Manufacturer
Reach out to Fresenius Kabi at Lake Zurich, IL 60047 for further assistance or to report concerns about the vial.
Questions people ask
What is the specific lot number for the recalled vials?
The lot number for the recalled vials is 6121083.
How can I tell if my vial is part of this recall?
Check for vials labeled 'Ketorolac Tromethamine Injection, USP, 30 mg per mL' with NDC 63323-162-00 or 63323-162-01 and lot number 6121083.
Is there a risk of serious injury from using these vials?
Yes, particulate matter in the vials could cause serious injury if injected into the body.
Contact Fresenius Kabi
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall D-0245-2021 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall D-0245-2021 from Fresenius 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-0245-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0245-2021 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.