Xylocaine-MPF with Epinephrine 1:200 — Class II drug recall D-0651-2021
Terminated recall by Fresenius Kabi USA LLC, reported 2021-07-14, distributed nationwide. Low out of specification results for epinephrine assay.
| Recall number | D-0651-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA LLC, Melrose Park, IL, United States |
| Recall initiated | 2021-06-25 |
| Classified | 2021-07-07 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2022-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 234,800 vials |
| Reason classes | potency, specification failure |
| NDC | 63323-0481, 63323-0481-01, 63323-0481-57, 63323-0482, 63323-0482-01, 63323-0482-03, 63323-0482-05, 63323-0482-17, 63323-0482-27, 63323-0482-57, 63323-0483, 63323-0483-01, 63323-0483-03, 63323-0483-27, 63323-0483-57, 63323-0484, 63323-0484-57, 63323-0485, 63323-0485-01, 63323-0485-03, 63323-0485-27, 63323-0485-57, 63323-0486, 63323-0486-01, 63323-0486-02 and 42 more |
| Lot numbers | 6123435, 6124730, 6124731 |
| Expiration dates | 2022-01, 2022-07 |
Product
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
Reason for recall
Low out of specification results for epinephrine assay.
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-0651-2021. 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.