Xylocaine-MPF with Epinephrine (Fresenius Kabi) – Epinephrine Assay (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Fresenius Kabi USA LLC
Lot Codes / Batch Numbers
Batch, expiry: Batch 6123435, exp 01/2022, 6124730, 6124731, exp 07/2022
Products Sold
Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg due to Low out of specification results for epinephrine assay.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Low out of specification results for epinephrine assay.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026