FlaggedRx← Medication recall checkHome
Class II · ModerateActive recall

Medline

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots 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
Where it was soldNationwide in the US
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMedline Industries, LP
Brand nameMEDLINE
Generic nameDIMETHICONE
Active ingredient(s)DIMETHICONE
Distributed by / forMedline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL)
NDC53329-159-13
Show the full FDA record
Full product labelMedline 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
Recalling firmBioMed Laboratories, LLC.
DistributionNationwide in the US
Quantity509,652 tubes
Recall initiated2026-06-11
Report date2026-07-15
Recall completed—
Recall numberD-0663-2026
ClassificationClass II
FDA statusOngoing
Origin on fileDallas TX United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.