Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recall
FDA recall D-0663-2026 · initiated Jun 11, 2026
BioMed Laboratories, LLC. recalled Medline Remedy Specialized Silicone Cream (Hydraguard-D ) in Jun 2026 — an FDA Class II recall (D-0663-2026) because Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 509,652 tubes
Details
- 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
- Recalling company
- BioMed Laboratories, LLC.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Jun 11, 2026
- FDA report date
- Jul 15, 2026
Frequently asked
- Was Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recalled?
- BioMed Laboratories, LLC. recalled Medline Remedy Specialized Silicone Cream (Hydraguard-D ) in Jun 2026 — an FDA Class II recall (D-0663-2026) because Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recalled?
- Per the FDA enforcement record, the reason for recall D-0663-2026 was: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
- Is a recalled Medline Remedy Specialized Silicone Cream (Hydraguard-D ) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Medline Remedy Specialized Silicone Cream (Hydraguard-D ) are affected?
- Distributed: Nationwide in the US. The recall covers these lots — 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 202…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0663-2026.