Fresenius Kabi Recalls Ketorolac Injection Due to Particulate Matter
Fresenius Kabi recalls over 5 million vials of Ketorolac Tromethamine Injection due to particulate matter. Check lot numbers and expiration dates for affected units.
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Presence of Particulate Matter - found in reserve sample vials at the firm.
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What happened, in plain English
Fresenius Kabi USA, LLC is recalling Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL single-dose vials because particulate matter was found in reserve sample vials. The recall affects approximately 5,314,400 vials distributed nationwide and in Puerto Rico. No specific remedy or action steps are currently stated in the record. Read more at govinfonow.com/recall/37135-fresenius-kabi-recalls-ketorolac-injection-due-to-particulate-matter.
Source Summary by GovInfoNow · govinfonow.com/recall/37135-fresenius-kabi-recalls-ketorolac-injection-due-to-particulate-matter · Updated October 11, 2026 · FDA enforcement record: FDA #D-1296-2020
Cite this page
“Fresenius Kabi Recalls Ketorolac Injection Due to Particulate Matter.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37135-fresenius-kabi-recalls-ketorolac-injection-due-to-particulate-matter. 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
The presence of particulate matter in the injection vials poses a risk because foreign particles could be introduced into a patient's bloodstream during administration. This can potentially cause serious health complications, which is why the recall is classified as Class I, the most serious category.
Who’s affected
Healthcare providers and patients in the USA and Puerto Rico who received Ketorolac Tromethamine Injection from the affected lots. Patients using this medication for intramuscular (IM) or intravenous (IV) administration are at risk of exposure to particulate matter.
How to tell if you have this one
Check if you have Ketorolac Tromethamine Injection, USP, 30 mg per mL in 1 mL single-dose vials manufactured by Fresenius Kabi. Affected lots are 6118737 (Exp 04/2020), 6118902 (Exp 05/2020), 6119052 (Exp 05/2020), 6119752 (Exp 08/2020), 6122349 (Exp 07/2021), and 6122538 (Exp 09/2021). The NDCs are 63323-162-00 (single vial) and 63323-162-01 (25 vials per tray).
- 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 |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-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 qwen3.6:35b-a3b on October 11, 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.