FDA recall D-0663-2026

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 for recall

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Distribution

Nationwide in the US

Key facts

Status

Ongoing

Initiation date

2026-06-11

Report date

2026-07-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0663-2026