Official recall notice
FDA DrugClass IINotable
FDA Recall: Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, T
- Recall date
- 2026-07-15
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Product description
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Affected products
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