FDA recall, , Moderate risk
Medline Remedy Specialized Silicone Cream (Hydraguard-D)
Medline Remedy Specialized Silicone Cream has formaldehyde levels exceeding specification.
Summary by Recall Canary from the FDA notice
What happened
BioMed Laboratories, LLC, of Dallas, Texas, recalled Medline Remedy Specialized Silicone Cream (Hydraguard-D), manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, because the raw material had an out of specification (OOS) result for formaldehyde. Formaldehyde levels exceeded specification, failing impurities and degradation specifications. The recall began June 11, 2026, and was added to the FDA's Enforcement Report on July 7, 2026.
The product was distributed nationwide in the US. The recall involved 509,652 tubes.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC or UPC and lot code are listed under that product.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Medline Remedy Specialized Silicone Cream (Hydraguard-D)
- NDC
- 53329-159-13
- 53329-159-04
- UPC
- 0001882643
- 0001887165
- 0001888441
- 0001900835
- 0001931329
- 0001951664
- 0001882644
- 0001899186
- 0001903516
- 0001905970
- 0001911902
- 0001917707
- 0001920638
- 0001927080
- 0001937896
- 0001952194
- 0001962232
- 0001981964
- 0001981965
- 0001994680
- 002012768
- 0001998027
- 002012787
- Lot code
- Jan-2027
Recall details
- Company began the recall
- Sold in
Nationwide in the US
- Company
- BioMed Laboratories, LLC.Dallas, Texas
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99234
- Recall number
- D-0663-2026
- Quantity recalled
- 509,652 tubes
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
