Biomed Laboratories, Llc.: Medline Remedy Specialized Silicone Cream (hydraguard-d )
Recall Summary Medline Remedy Specialized Silicone Cream (Hydraguard-D) in 2 FL OZ and 4 FL OZ sizes is being recalled because formaldehyde levels in the product exceeded safe specifications. The cream was distributed nationwide across all U.S. states and Washington, D.C. This is a Class II recall, meaning the product could cause adverse health effects but is unlikely to cause serious harm.
- 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/f029dffb-00be-427e-a5e4-7f68b1594346