FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

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

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 23, 2026 at 11:04 PM UTC.

Report a data error on this page