BioMed Laboratories, LLC. — Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-1
⚠️ Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 11, 2026
Nationwide in the US
What's affected?
- 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
- Brand
- MEDLINE
- Lot code
- 0001882643
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 509,652 tubes.
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