US Pharmaceuticals Inc. recalls Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline
US Pharmaceuticals recalls 3.5 oz Soothe & Cool Protect Moisture Guard tubes due to microbial contamination in purified water. Affected products have specific lot numbers and expiration dates.
Lower-risk recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Contact the company & request your remedy
What happened, in plain English
US Pharmaceuticals is recalling 3.5 oz Soothe & Cool Protect Moisture Guard skin protectant tubes because the purified water used in production had microbial contamination. This could potentially cause skin irritation or infection if the product is used. Read more at govinfonow.com/recall/39378-us-pharmaceuticals-soothe-cool-skin-protectant-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39378-us-pharmaceuticals-soothe-cool-skin-protectant-recall-microbial-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0425-2019
Cite this page
“US Pharmaceuticals Soothe & Cool Skin Protectant Recall: Microbial Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39378-us-pharmaceuticals-soothe-cool-skin-protectant-recall-microbial-contamination-risk. Based on FDA recall #D-0425-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0425-2019%22&limit=1).
Why it’s dangerous
The product contains purified water that tested out of specification for microbial count. This means the water could have bacteria or other microorganisms that might cause skin irritation or infection when applied to the skin.
Who’s affected
People who own or use the recalled skin protectant tubes, particularly those with sensitive skin or open wounds. Those who have the specific lot numbers mentioned in the recall are most at risk.
How to tell if you have this one
Check for 3.5 oz tubes labeled 'Soothe & Cool Protect Moisture Guard Skin Protectant' with lot numbers 50G17 (expires 5/2019) or 76J17 (expires 7/2019).
- Brand
US Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0425-2019 | Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22; Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019 | 19752 units | — |
| D-0426-2019 | Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03; Lot #: 36G17, 47G17, Exp. 5/2019; 84J17, Exp. 7/2019 | 67848 units | 0363-0237-02, 0363-0237-03 |
| D-0427-2019 | 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.; Lot # a) and b): 44G17, Exp. 05/2019 | 7020 units | — |
What to do — step by step
Check Product Details
Look for the lot numbers 50G17 or 76J17 on the tube's label, which expire in May 2019 or July 2019 respectively.
Questions people ask
Is this product safe to use?
The recall indicates potential microbial contamination in the purified water used in production, which could cause skin irritation or infection. The product is not safe to use as recalled.
How can I tell if I have the recalled product?
Check for 3.5 oz tubes labeled 'Soothe & Cool Protect Moisture Guard Skin Protectant' with lot numbers 50G17 (expires 5/2019) or 76J17 (expires 7/2019).
What should I do if I have the recalled product?
The recall does not specify a remedy, so you should check the product details and contact US Pharmaceuticals if you have concerns.
Contact US Pharmaceuticals
We’ve drafted a message you can send US Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0425-2019 — US Pharmaceuticals US Pharmaceuticals Hello, I own a US Pharmaceuticals that is covered by recall D-0425-2019 from US Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0425-2019 (December 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0425-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.