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# Fresenius Kabi Recalls 1 Lot of Dexmedetomidine
- URL: https://www.fdaweb.com/fresenius-kabi-recalls-1-lot-of-dexmedetomidine/
- Published: 2020-11-20T12:00:00.000Z
- Updated: 2026-09-14T16:37:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148141

Fresenius Kabi has recalled a single lot of dexmedetomidine HCl 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL) in a 50 mL vial due to a trace amount of lidocaine present in the lot. To date, no adverse drug experience reports have been received for the recalled lot, a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-single-lot-dexmedetomidine-hydrochloride-injection?ref=fdaweb.com) says. “Administration of dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction,” it says. The drug product is approved for intravenous use and indicated for sedation of non-intubated patients prior to or during surgical and other procedures.