FDAClass II · Drug · Recalled July 15, 2026

Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recall — BioMed Laboratories, LLC.

Hazard: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0663-2026
Brand: BioMed Laboratories
Classification: Class II
Units affected: 509,652 tubes
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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

Affected products

Medline Remedy Specialized Silicone Cream (Hydraguard-D )

Companies & origin

Recalling firm location: Dallas, TX, United States
Firm address: 8181 Eastpoint Dr Ste 100-500, N/A, 75227-2074

Identifying details (verbatim from the notice)

Product codes / lots: 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
Firm notified the public via: Letter
FDA event ID: 99234
Recall initiated: June 11, 2026
FDA classified: July 7, 2026
FDA report date: July 15, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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