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 #: A352405
- 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 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.
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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
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Safety Guide
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