Accueil/Tous les Rappels/FDA-D-0663-2026
FDA DrugsClass II

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

Publié le: 15 juillet 2026ID du rappel: D-0663-2026Catégorie: Médicaments & SantéPays: États-Unis
US
PharmaceuticalFDA DrugsUSUS

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

Recalling Firm: BioMed Laboratories, LLC.

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Traduire l’alerteTranslate notice text, hazard warnings, and descriptions into any supported language.

Motif du rappel / Danger

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Description du produit & Identification

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

Produits concernés

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

Additional Source Details

FieldValue
CityDallas
StateTX
Openfda › NuiN0000010282
Openfda › Unii92RU3N3Y1O
Openfda › RouteTOPICAL
Openfda › Rxcui2613881
Openfda › Spl id18582056-72e0-f103-e063-6394a90a1de2
Openfda › Brand nameMEDLINE
Openfda › Spl set idddab5235-1188-3866-e053-2a95a90a7a31
Openfda › Package ndc › 153329-159-13
Openfda › Package ndc › 253329-159-04
Openfda › Package ndc › 353329-159-77
Openfda › Package ndc › 453329-159-96
Openfda › Package ndc › 50001882643
Openfda › Package ndc › 60001887165
Openfda › Package ndc › 70001888441
Openfda › Package ndc › 80001900835
Openfda › Package ndc › 90001931329
Openfda › Package ndc › 100001951664
Openfda › Package ndc › 110001882644
Openfda › Package ndc › 120001899186
Openfda › Package ndc › 130001903516
Openfda › Package ndc › 140001905970
Openfda › Package ndc › 150001911902
Openfda › Package ndc › 160001917707
Openfda › Package ndc › 170001920638
Openfda › Package ndc › 180001927080
Openfda › Package ndc › 190001937896
Openfda › Package ndc › 200001952194
Openfda › Package ndc › 210001962232
Openfda › Package ndc › 220001981964
Openfda › Package ndc › 230001981965
Openfda › Package ndc › 240001994680
Openfda › Package ndc › 250001998027
Openfda › Product ndc53329-159
Openfda › Generic nameDIMETHICONE
Openfda › Product typeHUMAN OTC DRUG
Openfda › Pharm class peSkin Barrier Activity [PE]
Openfda › Substance nameDIMETHICONE
Openfda › Manufacturer nameMedline Industries, LP
Openfda › Application numberM016
Openfda › Is original packagertrue
Event id99234
Address 18181 Eastpoint Dr Ste 100-500
Address 2N/A
Code infoLots 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 code75227-2074
Report date20260715
Product typeDrugs
Product quantity509,652 tubes
Reason for recallFailed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260611
Initial firm notificationLetter
Center classification date20260707

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

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 Guide

Q1: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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Aperçu

  • Entreprise responsableBioMed Laboratories, LLC.
  • StatusOngoing
  • Niveau de risqueClass II
  • DistributionNationwide in the US
Recall Hazard Severity
High Alert (Class I)
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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

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Spread the WordMedline 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

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