Class II U.S. Food and Drug Administration

BioMed Laboratories, LLC. Medline Remedy Specialized Silicone Cream recall: Failed Impurities/Degradation Specifications

Recall published 3 months ago

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

The hazard: Harmful chemical exposure

This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

What the notice says: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0663-2026
Published
July 15, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
BioMed Laboratories, LLC.
Product type
Prescription & OTC drugs
Units affected
509,652 tubes
Distribution
Nationwide
Made in
United States
Lot / code info
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

Products covered by this recall

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

Check your product

The notice names 25 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0001882643
  • 0001887165
  • 0001888441
  • 0001900835
  • 0001931329
  • 0001882644
  • 0001899186
  • 0001903516
  • 0001905970
  • 0001911902
  • 0001917707
  • 0001952194
  • 0001981964
  • 0001981965
  • 0001994680
  • 0001998027
  • Jun 2027 Lot 002012787
  • Aug 2027 — 509
  • 652 tubes

NDC number

On the carton and again on the bottle or blister label.

  • 53329-159-13
  • 53329-159-04

Package size

Match the net weight or the piece count on the front of the pack.

  • 2 FL OZ
  • 59 mL
  • 4 FL OZ
  • 118 mL

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Chemical

BioMed Laboratories, LLC. — This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

  1. Stop using the product and keep it away from children and pets.
  2. Ventilate the room if the product was sprayed or applied there.
  3. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.
  4. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.

Company contact: BioMed Laboratories, LLC. — 8181 Eastpoint Dr Ste 100-500, Dallas, TX, 75227-2074

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was BioMed Laboratories, LLC. prescription & otc drugs recalled?

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 0001882643, 0001887165, 0001888441. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and keep it away from children and pets.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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