Dexmedetomidine HCl in 0 — Class I drug recall D-1537-2020
Terminated recall by Fresenius Kabi USA, LLC, reported 2020-09-02, distributed nationwide. Cross Contamination with other products: trace amounts of lidocaine
| Recall number | D-1537-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2020-07-22 |
| Classified | 2020-08-21 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2022-09-12 |
| Distributed | Nationwide (US) |
| Quantity | 25,100 bottles |
| NDC | 63323-0671-05 |
| Lot numbers | 6121853, 6122207 |
| Expiration dates | 2021-05, 2021-06 |
Product
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
Reason for recall
Cross Contamination with other products: trace amounts of lidocaine
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1537-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.