Skin Protectant With Lanolin Cream
FDA Recall NDC 68599-6203
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 Skin Protectant With Lanolin (NDC 68599-6203). A significant event, classified as Class II, was initiated on Aug 27, 2025 by Mckesson. The reported reason for this action was: "CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated."
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
August 2025 Class II Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall Number
Class II Ongoing
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Aug 27, 2025
Nov 26, 2025
5,876 units
Recall Profile & Regulatory Data
Event ID
97625
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
DermaRite Industries, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.
Batch or Lot Expiration Information
Lot# All lots on or before expiry date 08/2027
Affected Packages Involved in this Recall
68599-6202-1Product
68599-6202-2Product
68599-6202-4Product
68599-6203-1Product
68599-6203-4Product
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.
