D-0663-2026 Class II Ongoing
FDA drug recall D-0663-2026 was initiated by BioMed Laboratories, LLC. on June 11, 2026 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. The recall status is ongoing. Affected quantity: 509,652 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 15, 2026
- Initiation Date
- June 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 509,652 tubes
Product Description
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.
Distribution Pattern
Nationwide in the US
Code Information
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