HIGHFDA DRUG

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.

Official notice
ZINC OXIDEDynarex CorporationHealth & Personal CareDrugs & MedicationsLot #: A062434Exp. Date 6/27 & A062449Exp. Date 7/27

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
7/10

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

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
ZINC OXIDE, Dynarex Corporation
Product type
Zinc Oxide Ointment
Model numbers
Lot #: A062434, Exp. Date 6/27 & A062449, Exp. Date 7/27
UPC codes
67777-223, 67777-223-01, 67777-223-11, 67777-223-02, 67777-223-03, 67777-223-13, 67777-223-04, 67777-223-05 +1 more
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 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.

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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

  • Manufactured for Dynarex Corporation
  • Lot numbers: A062434, A062449
  • 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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