RecallRadar
ModerateReported July 15, 2026 (7 weeks 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.

Who this recall affects

This recall matters to anyone who bought Medline Remedy Specialized Silicone Cream (Hydraguard-D ). Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.

Distribution listed in the notice: Nationwide in the US.

What chemical impurity actually means

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.

In this case, the concern applies specifically to Medline Remedy Specialized Silicone Cream (Hydraguard-D ) from BioMed Laboratories, LLC. — not to the wider category of products. Similar items from other brands aren't part of this recall.

How to check whether you have it

On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.

Compare what you find against the identifying details in this recall: 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 000198

What to do if you already bought it

Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.

Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.

If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.

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.

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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 September 5, 2026.