Polocaine Injection, Solution
FDA Recall NDC 66312-441
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Polocaine (NDC 66312-441). A significant event, classified as Class II, was initiated on Oct 31, 2025 by Dentsply Pharmaceutical. The reported reason for this action was: "Defective container: cracked/broken cartridges"
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
Defective container: cracked/broken cartridges
Oct 31, 2025
Dec 24, 2025
5,825
Recall Profile & Regulatory Data
Event ID
98080
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Novocol Pharmaceutical of Canada, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.
Batch or Lot Expiration Information
Lot# Lot: D05159C, expires: 07-31-2027
Affected Packages Involved in this Recall
66312-441-16Product
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.
