FDAFDA recall D-0663-2026 · Jul 15, 2026
BioMed Laboratories, LLC.: Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Quantity
- 509,652 tubes
- Distribution
- Nationwide in the US
- Recalling firm
- BioMed Laboratories, LLC., Dallas, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-11
Source: openFDA enforcement record D-0663-2026 · search recall number D-0663-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.