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Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Indust… Recalled: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Medline Remedy Specialized Silicone Cream (Hydraguard-D… was recalled on June 11, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification..

Is my unit affected?

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

Model, lot & date codes to check

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

Units affected: 509,652 tubes

Where it was sold: Nationwide in the US

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: BioMed Laboratories, LLC.

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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