Recall: D-0663-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-11Initiated

OngoingStatus

BioMed Laboratories, LLC.Firm

Product

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

Reason

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Distribution

Nationwide in the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.