RECALL DATABASE

Silicone Cream Recall: Medline Remedy Hydraguard-D

Announced 2026-07-15 · FDA

The FDA is recalling 509,652 tubes of BioMed Laboratories, LLC's Medline Remedy Specialized Silicone Cream (Hydraguard-D), manufactured for Medline Industries, LP, distributed nationwide in the United States. The recall is due to failed impurities/degradation specifications with formaldehyde levels exceeding the specification. The affected lots span multiple dates from May 2026 through Aug 2027 and include several lot numbers listed in the recall notice.

BrandBioMed Laboratories, LLC.
ProductMedline 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
ReasonFailed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Severitymoderate
Units affected509652
DistributionNationwide in the US
AgencyFDA
Recall / campaign no.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

WHAT YOU SHOULD DO

  1. Stop using any product from the recalled lots.
  2. Check your product's lot number against the listed recalled lots.
  3. If affected, discontinue use and follow disposal or return instructions from Medline or the FDA.
  4. Contact Medline or the FDA for further guidance.

This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.