HIGH

Nivagen Zinc Oxide Ointment Recalled Due to cGMP Deviations

Nivagen Pharmaceuticals recalled 13,536 containers of zinc oxide ointment on October 31, 2025. The recall follows deviations from current Good Manufacturing Practices (cGMP). Consumers must stop using the product immediately and contact healthcare providers for guidance.

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brands
NIVAGEN ZINC OXIDE, Nivagen Pharmaceuticals, Inc.
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

Nivagen Zinc Oxide Ointment is commonly used for skin irritations, including diaper rash and minor burns. It provides protective and soothing benefits, making it popular among parents and caregivers.

Why This Is Dangerous

cGMP deviations can lead to inconsistent product quality, which may result in ineffective treatment or other health risks for consumers.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers who have purchased this product should immediately stop using it to avoid any potential health risks. The recall may cause inconvenience as consumers seek alternatives.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the product.
  2. Look for Lot #: A352405 to determine if your product is affected.
  3. Verify the product's packaging for any recall notices.

Where to find product info

The lot number is typically printed on the bottom of the container or on the label.

What timeline to expect

Expect a refund or resolution to take approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Contact Blossom Pharmaceuticals directly for assistance.
  • Reach out to the retailer for further options.

How to prevent similar issues

  • When purchasing medications, look for FDA approval and check for recall history.
  • Always inspect packaging for signs of tampering or damage before use.
  • Consult with a healthcare provider if uncertain about product safety.

Documentation advice

Keep receipts, product packaging, and any correspondence with the manufacturer as evidence of purchase and recall.

Product Details

The recalled product is Nivagen Zinc Oxide Ointment, net weight 1 oz. (28.4g). The lot number affected is A352405. It was distributed nationwide in the USA.

Key Facts

  • Recall date: October 31, 2025
  • Quantity recalled: 13,536 containers
  • Manufactured by: Nivagen Pharmaceuticals, Inc.
  • Lot number: A352405
  • Hazard classification: 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
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: A352405
UPC Codes
75834-170
75834-170-01
75834-170-02
+1 more
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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