Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, No
Summary
The FDA issued a Class II for Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medli by BioMed Laboratories, LLC.. Reason: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification..
Details
Source
Drug Recall
External ID
D-0663-2026
Action Date
2026-07-15
Status
Ongoing
Category
drug
Product Description
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
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
Quantity Affected: 509,652 tubes
Reason for Recall
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-11
Company
Dallas, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 93 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioMed Laboratories, LLC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioMed Laboratories, LLC. have FDA actions?
This is the only FDA action we have on record for BioMed Laboratories, LLC. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0663-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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