CLASS II ONGOING Drug recall · Reported 15 Jul 2026 · FDA Enforcement Report
Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recalled
BioMed Laboratories is recalling Medline Remedy Specialized Silicone Cream (Hydraguard-D ), distributed nationwide in the US. The recall was initiated on 11 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0663-2026
- FDA event ID
- 99234
- Recalling firm
- BioMed Laboratories, Dallas, TX
- Brand
- Medline
- Manufacturer
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jun 2026
- FDA classified
- 7 Jul 2026
- Reported
- 15 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 11 Jun 2026 | Recall initiated by company | |
| 7 Jul 2026 | Classified by FDA | +26 days |
| 15 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Which lots are affected?
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
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Dimethicone recalls
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|---|---|---|---|---|---|
| Drug | CLASS II | Comfort Shield (dimethicone) Barrier Cream Cloths recalledComfort Shield Barrier | Sage Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Comfort Shield (dimethicone) Barrier Cream Cloths recalledComfort Shield Barrier | Sage Products | Sterility | Nationwide |
| Drug | CLASS II | Comfort Shield Barrier Cream Cloths with dimethicone a) recalledComfort Shield Barrier | Sage Products | Sterility | Nationwide |