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.
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
- Check the lot number on the product.
- Look for Lot #: A352405 to determine if your product is affected.
- 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.