Medline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
Medline Remedy Specialized Silicone Cream is being recalled because formaldehyde levels exceeded the product specification. BioMed Laboratories is recalling approximately 509,652 tubes distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves an impurity (elevated formaldehyde) detected during quality control testing; the source text does not indicate that the formaldehyde levels pose an immediate or serious health threat or that any adverse health consequences have occurred.
Plain-English summary
Medline Remedy Specialized Silicone Cream (Hydraguard-D), a topical dimethicone product manufactured by BioMed Laboratories, LLC, is being recalled due to failed impurities and degradation specifications. Testing revealed that formaldehyde levels in the product exceeded specification limits.
The recalled product is available in two sizes: 2 FL OZ (59 mL) with NDC 53329-159-13 and 4 FL OZ (118 mL) with NDC 53329-159-04. Approximately 509,652 tubes have been distributed nationwide. The recall affects multiple lot numbers manufactured between May 2026 and August 2027.
Consumers and healthcare facilities in possession of affected lots should stop using the product and contact their supplier or BioMed Laboratories, LLC for return instructions. Consumers with questions may contact the FDA or the recalling firm.
The recalled product
- Product
- MEDLINE (DIMETHICONE)
- Brand
- MEDLINE
- Manufacturer
- BioMed Laboratories, LLC.
- Category
- Drug — OTC Topical
- Hazard
- formaldehyde
- impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Distribution
Distributed nationwide across the United States.
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