Medline Cream
FDA Recall NDC 53329-159
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 Medline (NDC 53329-159). A significant event, classified as Class II, was initiated on Jun 11, 2026 by Medline Industries, Lp. The reported reason for this action was: "Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification."
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
June 2026 Class II Recall: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Jun 11, 2026
Jul 15, 2026
509,652 tubes
Recall Profile & Regulatory Data
Event ID
99234
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
BioMed Laboratories, LLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04
Batch or Lot Expiration Information
Lot# Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707 & 0001920638 June 2026 Lot 0001927080 Oct 2026 Lots 0001937896, 0001952194 & 0001962232, Jan-2027 Lots 0001981964, 0001981965, 0001994680 & 002012768, May 2027 Lot 0001998027, Jun 2027 Lot 002012787, Aug 2027
Affected Packages Involved in this Recall
53329-159-13Product
53329-159-04Product
53329-159-77Product
53329-159-96Product
0001882643Product
0001887165Product
0001888441Product
0001900835Product
0001931329Product
0001951664Product
0001882644Product
0001899186Product
0001903516Product
0001905970Product
0001911902Product
0001917707Product
0001920638Product
0001927080Product
0001937896Product
0001952194Product
0001962232Product
0001981964Product
0001981965Product
0001994680Product
0001998027Product
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.
