FDA Drugs recall · July 15, 2026

Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for… recall

Recall number: D-0663-2026
Date: July 15, 2026 (initiated June 11, 2026)
Company / brand: BioMed Laboratories, LLC.
8181 Eastpoint Dr Ste 100-500, Dallas, TX, United States
Category: Drugs › Class II
Classification: Class II
Status: Ongoing
Units affected: 509,652 tubes
Initiated by: Voluntary: Firm initiated

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

Why was it recalled?

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707 & 0001920638 June 2026 Lot 0001927080 Oct 2026 Lots 0001937896, 0001952194 & 0001962232, Jan-2027 Lots 0001981964, 0001981965, 0001994680 & 002012768, May 2027 Lot 0001998027, Jun 2027 Lot 002012787, Aug 2027

Distribution

Nationwide in the US

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0663-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.