BioMed Laboratories, LLC.: Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the US
- Recall initiated
- 2026-06-11
- 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
- Product quantity
- 509,652 tubes
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Dallas
- State
- TX
- Country
- United States
- Event id
- 99234
Free daily digest + "My products" watchlist