CLASS I Drug recall · Reported 3 Feb 2021 · FDA Enforcement Report
Ketorolac Tromethamine Injection, USP, 30 mg per mL recalled
Fresenius Kabi USA is recalling Ketorolac Tromethamine Injection, USP, 30 mg per mL, distributed nationwide in the US. The recall was initiated on 23 Dec 2020 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0245-2021
- FDA event ID
- 87082
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 23 Dec 2020
- FDA classified
- 27 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 23 Dec 2020 | Recall initiated by company | |
| 27 Jan 2021 | Classified by FDA | +35 days |
| 3 Feb 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter - found in reserve sample vials at the firm.
Product as listed by the FDA
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.
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter - found in reserve sample vials at the firm.
Which lots are affected?
Lot # 6121083, Exp 2/2021
Where was it sold?
Nationwide USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 94| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Ketorolac Tromethamine recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketorolac Tromethamine Injection, USP, 60 mg recalled by Aspiro PharmaKetorolac Tromethamine | Aspiro Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |