Warning
BioMed Laboratories Recalls Medline Remedy Specialized Silicone Cream (Hydraguard-D )
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0663-2026Drug / Pharmaceutical
BioMed Laboratories Recalls Medline Remedy Specialized Silicone Cream (Hydraguard-D )
BioMed Laboratories, LLC. · Class II — Moderate Risk
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
Reason for Recall
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the US
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. BioMed Laboratories, LLC. initiated the recall on June 11, 2026 affecting 509,652 tubes. Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact BioMed Laboratories, LLC. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.