Naropin Injection, Solution
FDA Recall NDC 63323-285
Latest: Class II · Status: Ongoing · Initiated Jul 16, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Naropin (NDC 63323-285). A significant event, classified as Class II, was initiated on Jul 16, 2026 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Presence of Particulate Matter: Hair was found in products"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Particulate Matter: Hair was found in products
Jul 16, 2026
Jul 29, 2026
92,600 vials
Recall Profile & Regulatory Data
Event ID
99449
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within in the USA
Product Description
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
Batch or Lot Expiration Information
Lot# : 6133436, Exp. Date 10/2028
Affected Packages Involved in this Recall
63323-286-01Naropin
63323-286-20Naropin
63323-286-05Naropin
63323-286-23Naropin
63323-286-09Naropin
63323-286-31Naropin
63323-286-11Naropin
63323-286-35Naropin
63323-286-03Naropin
63323-286-00Naropin
63323-286-33Naropin
63323-286-63Naropin
63323-286-30Naropin
63323-287-01Naropin
63323-287-20Naropin
63323-287-03Naropin
63323-287-21Naropin
63323-288-01Naropin
63323-288-10Naropin
63323-288-06Naropin
63323-288-20Naropin
63323-288-03Naropin
63323-288-11Naropin
63323-288-07Naropin
63323-288-21Naropin
63323-285-01Naropin
63323-285-10Naropin
63323-285-06Naropin
63323-285-20Naropin
63323-285-03Naropin
63323-285-13Naropin
63323-285-07Naropin
63323-285-23Naropin
63323-285-57Naropin
63323-285-64Naropin
63323-285-51Naropin
63323-285-65Naropin
63323-285-02Naropin
63323-285-61Naropin
63323-285-04Naropin
63323-285-63Naropin
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
