Biomed Laboratories, Llc.: Medline Remedy Specialized Silicone Cream (hydraguard-d )
Recall Summary Medline Remedy Specialized Silicone Cream (Hydraguard-D) in 2 oz and 4 oz bottles is being recalled nationwide because formaldehyde levels in the product exceeded acceptable limits. The cream was manufactured by BioMed Laboratories for Medline Industries and distributed across all U.S. states and Washington, D.C. This is a Class II recall, meaning the product could cause adverse health effects.
- Recalling firm
- BioMed Laboratories, LLC.
- 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.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-11
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the US
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/8968e40e-73c2-431b-a802-93759e860b93