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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- NIVAGEN ZINC OXIDE, Nivagen Pharmaceuticals, Inc.
- Product type
- Zinc Oxide Ointment
- Model numbers
- Lot #: A352505
- UPC codes
- 75834-170, 75834-170-01, 75834-170-02, 75834-170-15
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 31, 2025
Reported by FDA DRUG
December 10, 2025
RecallRadar source check
December 17, 2025
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
Nivagen Zinc Oxide Ointment is used for skin protection and is commonly purchased for its soothing and barrier properties for diaper rash and minor skin irritations.
Why This Is Dangerous
The cGMP deviations may result in inconsistencies in the product's formulation or contamination, posing risks to consumers.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face inconvenience and potential health risks if they continue to use the affected ointment.
Practical Guidance
How to identify if yours is affected
- Check the product label for the lot number A352505.
- Verify if the product has been used or is still unopened.
- Contact your healthcare provider for confirmation of the recall.
Where to find product info
The lot number can typically be found on the bottom of the tube or box packaging.
What timeline to expect
Refund processing may take 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Blossom Pharmaceuticals after two weeks.
- Contact the FDA for assistance if still unresolved.
How to prevent similar issues
- Always check for product recalls before purchasing.
- Look for FDA approval and cGMP certification when buying medications.
- Consult with a healthcare provider for recommendations on safe alternatives.
Documentation advice
Keep receipts, correspondence with the manufacturer, and take photos of the product for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is Nivagen Zinc Oxide Ointment USP, containing 20% zinc oxide, and packaged in 1 oz. (28.4 g) bottles. The lot number is A352505, and it was distributed nationwide in the USA.
Key Facts
- Recall date: October 31, 2025
- Report date: December 10, 2025
- Quantity recalled: 7,920 bottles
- Manufactured in India
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
