Medline Remedy Specialized Silicone Cream Recall
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BioMed Laboratories, LLC. is recalling 509,652 tubes of Medline Remedy Specialized Silicone Cream due to elevated formaldehyde levels exceeding specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
BioMed Laboratories, LLC. initiated a voluntary recall of Medline Remedy Specialized Silicone Cream (Hydraguard-D) after the product failed impurities/degradation specifications because formaldehyde levels exceeded specification. The recall is classified as Class II by the FDA.
Which Products Are Affected
The affected product is Medline Remedy Specialized Silicone Cream (Hydraguard-D), manufactured for Medline Industries, LP. Sizes include 2 FL OZ (59 mL) NDC 53329-159-13 and 4 FL OZ (118 mL) NDC 53329-159-04, along with additional package NDCs. A total of 509,652 tubes are affected. Distribution was nationwide in the US. Affected lots include: 0001882643, 0001887165, 0001888441, 0001900835, 0001931329, 0001951664 (May 2026); 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707, 0001920638 (June 2026); 0001927080 (Oct 2026); 0001937896, 0001952194, 0001962232 (Jan-2027); 0001981964, 0001981965, 0001994680, 002012768 (May 2027); 0001998027 (Jun 2027); 002012787 (Aug 2027). Recall number is D-0663-2026.
What You Should Do
Consumers should not use the affected product and should contact the recalling firm or consult with a healthcare provider regarding the recall.
Why This Matters
The recall involves over 500,000 tubes distributed nationwide due to exceeded formaldehyde specifications in a topical OTC drug.
Source
FDA recall D-0663-2026, report date 20260715.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,429 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.