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 with particulate matter found in reserve samples. Affected lots expire by April 2020 through September 2021. Stop using immediately if you have these vials.
Stop using this now
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 contain particulate matter, a potentially dangerous impurity. This could cause serious injury if injected. The recall affects specific lots of vials that were sold between 2019 and 2021. Read more at govinfonow.com/recall/37135-fresenius-kabi-ketorolac-injection-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/37135-fresenius-kabi-ketorolac-injection-recall-particulate-matter-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-1296-2020
Cite this page
“Fresenius Kabi Ketorolac Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37135-fresenius-kabi-ketorolac-injection-recall-particulate-matter-hazard. Based on FDA recall #D-1296-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1296-2020%22&limit=1).
Why it’s dangerous
Particulate matter in the vials can enter the bloodstream during injection, potentially causing serious injury or death. This was discovered in reserve samples by the manufacturer.
Who’s affected
Patients prescribed Ketorolac injections by doctors who received these specific vial lots. Those with the recalled vials are at immediate risk of serious injury.
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. The affected lots have specific expiration dates from April 2020 through September 2021.
- Brand
Fresenius Kabi- Category
Drug
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.
- Status
Terminated- Distribution
USA Nationwide and Puerto Rico- NDC
63323-161-00, 63323-161-01, 63323-162-11, 63323-162-51, 63323-162-00, 63323-162-01, 63323-162-03, 63323-162-02
| Recall number | Product, codes & lots | Quantity | Class |
|---|---|---|---|
| D-1296-2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.; Lot #: 6118737, 6118902, Exp 04/2020; 6119052, Exp 05/2020; 6119752, Exp 08/2020; 6122349, Exp 07/2021; 6122538, Exp 09/2021 | 5,314,400 vials | Class I |
| D-1297-2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.; Lot #: 6119229, 6119273, Exp 06/2020; 6119843, Exp 09/2020; 6121115, Exp 02/2021; 6121451, 6121452, 6121496, Exp 03/2021 | 3,497,575 vials | Class II |
What to do — step by step
Stop Using Immediately
Discard the vials if you have them and contact your healthcare provider for alternative treatment options.
Questions people ask
What lots of Ketorolac vials are affected?
Lots 6118737, 6118902 (expiring April 2020), 6119052 (May 2020), 6119752 (August 2020), 6122349 (July 2021), and 6122538 (September 2021).
How can I tell if I have the recalled vials?
Look for vials with NDC 63323-162-00 and expiration dates from April 2020 through September 2021.
Is there a fix for this issue?
The manufacturer has not provided a fix; the remedy is to stop using the vials immediately and contact your healthcare provider.
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-1296-2020 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall D-1296-2020 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.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-1296-2020 (April 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1296-2020 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.