RecallRadar
ModerateReported July 15, 2026 (7 days ago)

Medline Remedy Specialized Silicone Cream (Hydraguard-D )

Recalled by BioMed Laboratories, LLC.

Product image for 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
Product image via news and web sources. It may show general packaging and not the exact recalled lot — always confirm using the codes below.

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

BioMed Laboratories, LLC. has recalled Medline Remedy Specialized Silicone Cream (Hydraguard-D ), according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on July 15, 2026 and was initiated on June 11, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Medline Remedy Specialized Silicone Cream (Hydraguard-D ), with approximately 509,652 tubes affected. The company behind the recall is BioMed Laboratories, LLC., based in Dallas, TX. The FDA describes the product as: “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 Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recalled?

According to the FDA, the stated reason for the recall is: “Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.” In plain terms, this recall relates to a chemical impurity.

This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.

What should you do?

If you think you may have bought Medline Remedy Specialized Silicone Cream (Hydraguard-D ), compare it against the product description and identifying codes (Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 00019177…) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact BioMed Laboratories, LLC. or your local health authority.

About this recall

This recall was distributed in TX. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Full recall details

Status
Ongoing
Date reported
July 15, 2026
Recall started
June 11, 2026
Distributed in
TX
What was recalled
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 it was recalled (as stated by the FDA)
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
How to identify the affected product
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
Amount recalled
509,652 tubes

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recalled?+

According to the FDA: Failed Impurities/Degradation Specifications;

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have Medline Remedy Specialized Silicone Cream (Hydraguard-D )?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

Share this recall:PostShareEmail
View the official FDA record

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0663-2026. Information last synced from the FDA on July 22, 2026.