HIGHFDA DRUG

Dynarex Recalls Wecare Calasoothe Ointment Over cGMP Violations

Dynarex Corporation recalled 2,400 containers of Wecare Calasoothe on October 31, 2025, due to cGMP deviations. The recall affects the 4 oz ointment, as it may not meet safety standards. Consumers should stop using the product immediately and consult their healthcare providers.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
October 31, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brands
MENTHOL AND ZINC OXIDE, Dynarex Corporation
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
MENTHOL AND ZINC OXIDE, Dynarex Corporation
Product type
Topical Ointment
Model numbers
Lot #: A482305
UPC codes
67777-234, 67777-234-02, 67777-234-01, 67777-234-04, 67777-234-03
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    October 31, 2025

  2. Reported by FDA DRUG

    December 10, 2025

  3. RecallRadar source check

    December 17, 2025

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

cGMP deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter

About This Product

Wecare Calasoothe is a topical ointment containing menthol and zinc oxide. Consumers typically use it for soothing skin irritations and minor wounds.

Why This Is Dangerous

The cGMP deviations may affect the product's quality and safety, potentially leading to ineffective treatment or adverse reactions.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face safety risks by using this product. Immediate action is necessary to prevent potential health issues.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on your product packaging.
  2. Verify if your product is Lot #: A482305.
  3. Stop using the product immediately if it matches the lot number.

Where to find product info

Lot numbers can typically be found on the bottom or side of the container.

What timeline to expect

Expect processing for refunds or replacements to take approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Document your communication attempts with the company.
  • Consider reaching out to consumer protection agencies for assistance.
  • Check back for updates from the manufacturer regarding the recall.

How to prevent similar issues

  • Look for products with current Good Manufacturing Practice certifications.
  • Verify the manufacturer's reputation before purchase.
  • Research product reviews to ensure safety and effectiveness.

Documentation advice

Keep copies of receipts, photographs of the product, and any communications with the manufacturer.

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Product Details

Wecare Calasoothe has a net weight of 4 oz (113 g) and is manufactured by Dynarex Corporation, located at 10 Glenshaw Street, Orangeburg, NY 10962. The product is identified by NDC 67777-234-04 and was distributed nationwide in the USA.

Key Facts

  • Recalled product: Wecare Calasoothe
  • Net weight: 4 oz (113 g)
  • Recall date: October 31, 2025
  • Manufacturer: Dynarex Corporation

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: A482305
UPC Codes
67777-234
67777-234-02
67777-234-01
+2 more
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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