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CLASS II · ModerateFDA

BioMed Laboratories, LLC. recalls Medline Remedy Specialized Silicone Cream

📅 Jun 11, 2026 · 📍 Nationwide
Recalling company
BioMed Laboratories, LLC.
Product
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
Reason
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jun 11, 2026
Reported
Jul 15, 2026
Distribution
Nationwide in the US
Status
Ongoing
Quantity
509,652 tubes
Lot / codes
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
Company location
Dallas, TX
Recall type
Voluntary: Firm initiated
Recall number
D-0663-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0663-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.