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
USMedline 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 Firm: BioMed Laboratories, LLC.
Motivo del Retiro / Peligro
TranslatedFailed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Descripción del Producto e Identificación
TranslatedMedline 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
Productos Afectados
TranslatedMedline 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
Additional Source Details
| Field | Value |
|---|---|
| City | Dallas |
| State | TX |
| Openfda › Nui | N0000010282 |
| Openfda › Unii | 92RU3N3Y1O |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 2613881 |
| Openfda › Spl id | 18582056-72e0-f103-e063-6394a90a1de2 |
| Openfda › Brand name | MEDLINE |
| Openfda › Spl set id | ddab5235-1188-3866-e053-2a95a90a7a31 |
| Openfda › Package ndc › 1 | 53329-159-13 |
| Openfda › Package ndc › 2 | 53329-159-04 |
| Openfda › Package ndc › 3 | 53329-159-77 |
| Openfda › Package ndc › 4 | 53329-159-96 |
| Openfda › Package ndc › 5 | 0001882643 |
| Openfda › Package ndc › 6 | 0001887165 |
| Openfda › Package ndc › 7 | 0001888441 |
| Openfda › Package ndc › 8 | 0001900835 |
| Openfda › Package ndc › 9 | 0001931329 |
| Openfda › Package ndc › 10 | 0001951664 |
| Openfda › Package ndc › 11 | 0001882644 |
| Openfda › Package ndc › 12 | 0001899186 |
| Openfda › Package ndc › 13 | 0001903516 |
| Openfda › Package ndc › 14 | 0001905970 |
| Openfda › Package ndc › 15 | 0001911902 |
| Openfda › Package ndc › 16 | 0001917707 |
| Openfda › Package ndc › 17 | 0001920638 |
| Openfda › Package ndc › 18 | 0001927080 |
| Openfda › Package ndc › 19 | 0001937896 |
| Openfda › Package ndc › 20 | 0001952194 |
| Openfda › Package ndc › 21 | 0001962232 |
| Openfda › Package ndc › 22 | 0001981964 |
| Openfda › Package ndc › 23 | 0001981965 |
| Openfda › Package ndc › 24 | 0001994680 |
| Openfda › Package ndc › 25 | 0001998027 |
| Openfda › Product ndc | 53329-159 |
| Openfda › Generic name | DIMETHICONE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class pe | Skin Barrier Activity [PE] |
| Openfda › Substance name | DIMETHICONE |
| Openfda › Manufacturer name | Medline Industries, LP |
| Openfda › Application number | M016 |
| Openfda › Is original packager | true |
| Event id | 99234 |
| Address 1 | 8181 Eastpoint Dr Ste 100-500 |
| Address 2 | N/A |
| Code info | 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 | 20260715 |
| Product type | Drugs |
| Product quantity | 509,652 tubes |
| Reason for recall | Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260611 |
| Initial firm notification | Letter |
| Center classification date | 20260707 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive,...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableBioMed Laboratories, LLC.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionNationwide in the US
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🚨 SAFETY ALERT: BioMed Laboratories, LLC. - 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 Check if your household is affected: https://therecallfile.com/es/recalls/medline-remedy-specialized-silicone-cream-hydraguard-d-manufactured-fo/FDA-D-0663-2026
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