Medline Silicone Cream Recall: Formaldehyde Risk
Medline recalls specialized silicone cream due to formaldehyde levels exceeding safety standards. Affected lots from May 2026 to August 2027 may pose health risks.
Lower-risk recall
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Contact the company
What happened, in plain English
Medline is recalling its Hydraguard-D silicone cream because it contains formaldehyde levels that exceed safe specifications. This could cause health issues if used as intended. Read more at govinfonow.com/recall/31209-medline-silicone-cream-recall-formaldehyde-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31209-medline-silicone-cream-recall-formaldehyde-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0663-2026
Cite this page
“Medline Silicone Cream Recall: Formaldehyde Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31209-medline-silicone-cream-recall-formaldehyde-risk. Based on FDA recall #D-0663-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0663-2026%22&limit=1).
Why it’s dangerous
The cream contains formaldehyde levels that exceed the manufacturer's safety specifications. Formaldehyde is a known irritant that can cause skin reactions in some users.
Who’s affected
People who purchased the Medline Hydraguard-D silicone cream with the listed lot numbers from May 2026 through August 2027 are affected. Those with sensitive skin or allergies may be at higher risk.
How to tell if you have this one
Check the product label for the lot numbers listed in the recall notice (e.g., 0001882643, 0001887165, etc.) and the expiration date (May 2026 to August 2027).
- Brand
Medline- Category
Drug
What to do — step by step
Check Product Label
Look for the lot numbers and expiration dates listed in the recall notice to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0663-2026 (June 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0663-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.