FDA Drug recall D-0663-2026
Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-15
On 2026-07-15 the FDA classified a Class II recall of Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090… by Biomed Laboratories, citing failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0663-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-11 |
| Published | 2026-07-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Biomed Laboratories |
| Distribution | US |
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.
Identifiers
| ndc | 53329-159-13 |
|---|---|
| ndc | 53329-159-04 |
| ndc | 53329-159-77 |
| ndc | 53329-159-96 |
| ndc | 0001882643 |
| ndc | 0001887165 |
| ndc | 0001888441 |
| ndc | 0001900835 |
| ndc | 0001931329 |
| ndc | 0001951664 |
| ndc | 0001882644 |
| ndc | 0001899186 |
| ndc | 0001903516 |
| ndc | 0001905970 |
| ndc | 0001911902 |
| ndc | 0001917707 |
| ndc | 0001920638 |
| ndc | 0001927080 |
| ndc | 0001937896 |
| ndc | 0001952194 |
| ndc | 0001962232 |
| ndc | 0001981964 |
| ndc | 0001981965 |
| ndc | 0001994680 |
| ndc | 0001998027 |
| code_info | Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 000188264…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0663-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.