Medline Remedy Specialized Silicone Cream — Class II drug recall D-0663-2026
Ongoing recall by BioMed Laboratories, LLC., reported 2026-07-15, distributed nationwide. Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
| Recall number | D-0663-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMed Laboratories, LLC., Dallas, TX, United States |
| Recall initiated | 2026-06-11 |
| Classified | 2026-07-07 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 509,652 tubes |
| Reason classes | specification failure |
| NDC | 53329-0159, 53329-0159-04, 53329-0159-13, 53329-0159-77, 53329-0159-96 |
| Lot numbers | 0001882643, 0001882644, 0001887165, 0001888441, 0001899186, 0001900835, 0001903516, 0001905970, 0001911902, 0001917707, 0001920638, 0001927080, 0001931329, 0001937896, 0001951664, 0001952194, 0001962232, 0001981964, 0001981965, 0001994680, 0001998027, 002012768, 002012787, JAN-2027 |
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 for recall
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0663-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.