Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported July 15, 2026
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
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
BioMed Laboratories, LLC. recalled Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Indust… - a moderate-severity action.
Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Indust… was recalled by BioMed Laboratories, LLC. in July 15, 2026. Reason: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.. Check the official notice for the remedy. Verify recall #D-0663-2026 with the FDA Drug before acting.
The recall
BioMed Laboratories, LLC. issued this moderate-severity FDA Drug recall-Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification..
- Moderate
- severity level
- Class II
- classification
- July 15, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0663-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0663-2026) was formally reported on July 15, 2026, with the manufacturer initiating the action on June 11, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. BioMed Laboratories, LLC. is listed as the recalling firm, operating out of Dallas, TX. Federal records list the affected scope as 509,652 tubes.
The documented reason for this recall is: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. Distribution data in the federal record shows the product reached: Nationwide in the US. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Cosmetics & Personal Care recalls over time
Where this recall sits in its category - 1,371 cosmetics & personal care recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
509,652 tubes
Related Recalls
6
3 from same agency
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
Reason for recall
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0663-2026 |
| Date reported | July 15, 2026 |
| Date initiated | June 11, 2026 |
| Recalling firm | BioMed Laboratories, LLC. |
| Firm location | Dallas, TX |
| Affected scope | 509,652 tubes |
| Distribution | Nationwide in the US |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0663-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by BioMed Laboratories, LLC.. Units affected: 509,652 tubes.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2026. Severity: Moderate. Recall number: D-0663-2026.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the US.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0663-2026) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Cosmetics & Personal Care · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
Showing 5 of 1387 other recalls in this category.
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CPSC No agency class
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Madewell Inc., of New York, New York · 2026-07-16
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TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lo…
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FDA Food Critical
2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.
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Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonn…
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Compare this recall with Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 7… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 15, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.