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

Recall Insight

This FDA Drug action (record #D-0651-2021) was formally reported on July 14, 2021, with the manufacturer initiating the action on June 25, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Fresenius Kabi USA LLC is listed as the recalling firm, operating out of Melrose Park, IL. Federal records indicate 234,800 vials units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Low out of specification results for epinephrine assay. Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.