CLASS I Drug recall · Reported 2 Sep 2020 · FDA Enforcement Report
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection recalled
Fresenius Kabi USA is recalling Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per (4 mcg per mL), for, distributed nationwide in the US. The recall was initiated on 22 Jul 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-1537-2020
- FDA event ID
- 86095
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 22 Jul 2020
- FDA classified
- 21 Aug 2020
- Reported
- 2 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Jul 2020 | Recall initiated by company | |
| 21 Aug 2020 | Classified by FDA | +30 days |
| 2 Sep 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination with other products: trace amounts of lidocaine
Product as listed by the FDA
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Cross Contamination with other products: trace amounts of lidocaine
Which lots are affected?
Lot #: 6121853, Exp 05/2021; 6122207, Exp 06/2021
Where was it sold?
U.S.A. Nationwide
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 95| 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 Dexmedetomidine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexmedetomidine Hydrochloride recalled by Baxter Healthcare | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection recalled | Fresenius Kabi USA | Other | Nationwide |
| Drug | CLASS II | Dexmedetomidine 400 mcg in NS, Made by: Enterprise Pharmacy recalled | CMC Enterprise Pharmacy | Sterility | NC |