HIGH

Dynarex Recalls Zinc Oxide Ointment Over cGMP Deviations

Dynarex Corporation recalled 2,592 bottles of WeCare Zinc Oxide Ointment on October 31, 2025, due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers and healthcare providers must stop using the ointment immediately and seek guidance.

Quick Facts at a Glance

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

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

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About This Product

WeCare Zinc Oxide Ointment is a topical treatment typically used for skin irritations, rashes, and minor burns. Consumers often buy this product for its protective properties, particularly for infants and individuals with sensitive skin.

Why This Is Dangerous

cGMP deviations indicate that the product may not have been manufactured to the required quality standards, potentially leading to contamination or ineffective treatment.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall poses a high risk due to potential safety issues, prompting immediate action from consumers and healthcare providers.

Practical Guidance

How to identify if yours is affected

  1. Check the product for lot numbers A062434 or A062449.
  2. Verify the expiration date: June 27, 2027, or July 27, 2027.
  3. Stop using the product if it matches the recalled lot numbers.

Where to find product info

Lot numbers and expiration dates are typically printed on the product packaging or label.

What timeline to expect

Expect a refund or replacement processing time of 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Document all communication attempts with the company.
  • Contact the FDA if the company does not respond.
  • Consider filing a complaint if issues persist.

How to prevent similar issues

  • Look for products with clear cGMP certifications when purchasing.
  • Research brands for recalls before buying similar products.
  • Read reviews and safety records of health and personal care items.

Documentation advice

Keep records of your purchase, including receipts and correspondence with the manufacturer for potential claims.

Product Details

The recalled product is WeCare Zinc Oxide Ointment, net weight 15 oz (425 g). It was manufactured for Dynarex Corporation, located at 11 Dynarex Drive, Middletown, NY 10941. The affected lot numbers are A062434 and A062449, with expiration dates of June 27, 2027, and July 27, 2027.

Key Facts

  • 2,592 bottles recalled
  • Manufactured for Dynarex Corporation
  • Lot numbers: A062434, A062449
  • Expiration dates: 6/27/2027, 7/27/2027
  • Recall classified as Class II

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: A062434
Exp. Date 6/27 & A062449
Exp. Date 7/27
UPC Codes
67777-223
67777-223-01
67777-223-11
+6 more
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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