Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported February 13, 2019
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
US Pharmaceuticals Inc. recalled Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a)… - a moderate-severity action.
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a)… was recalled by US Pharmaceuticals Inc. in February 13, 2019. Reason: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sa…. Check the official notice for the remedy. Verify recall #D-0427-2019 with the FDA Drug before acting.
The recall
US Pharmaceuticals Inc. issued this moderate-severity FDA Drug recall-GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sa….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- February 13, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0427-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0427-2019) was formally reported on February 13, 2019, with the manufacturer initiating the action on December 7, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. US Pharmaceuticals Inc. is listed as the recalling firm, operating out of Belleville, NJ. Federal records list the affected scope as 7020 units.
The documented reason for this recall is: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample Distribution data in the federal record shows the product reached: Nationwide within the United States. 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 - 1,360 cosmetics & personal care recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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
7020 units
Related Recalls
6
3 from same agency
Product description
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
Reason for recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0427-2019 |
| Date reported | February 13, 2019 |
| Date initiated | December 7, 2018 |
| Recalling firm | US Pharmaceuticals Inc. |
| Firm location | Belleville, NJ |
| Affected scope | 7020 units |
| Distribution | Nationwide within the United States |
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-0427-2019) 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 Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.. Recalled by US Pharmaceuticals Inc.. Units affected: 7020 units.
Why was this product recalled? ▼
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 13, 2019. Severity: Moderate. Recall number: D-0427-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0427-2019) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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FDA Drug Moderate
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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 February 13, 2019. 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 July 2026.