Why it was recalled
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Product description
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
Lot numbers, UPCs & expiration codes
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 it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0663-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 11, 2026
- FDA report date
- Jul 15, 2026
- Quantity
- 509,652 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BioMed Laboratories, LLC.
Original FDA data
Every field from FDA enforcement report D-0663-2026, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 99234
- Address
- 8181 Eastpoint Dr Ste 100-500
- Code information
- 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
- Postal code
- 75227-2074
- Report date
- Jul 15, 2026
- Product type
- Drugs
- Recall number
- D-0663-2026
- Classification
- Class II
- Recalling firm
- BioMed Laboratories, LLC.
- Product quantity
- 509,652 tubes
- Reason for recall
- Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jun 11, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 7, 2026