Quick Facts at a Glance
- Recall Date
- October 31, 2025
- Hazard Level
- HIGH
- Brand
- Nivagen Zinc Oxide
- 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
- Product type
- Zinc Oxide Ointment
- Model numbers
- A352318
- UPC codes
- 75834-170, 75834-170-01, 75834-170-02, 75834-170-15
- Sizes
- 15 oz (425 g)
- 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
March 18, 2026
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
Zinc oxide ointment is a topical skin protectant used to soothe and protect irritated skin. The 20% formulation is a high-concentration variant used in medical settings.
Why This Is Dangerous
cGMP deviations indicate manufacturing quality control issues that could affect product safety or potency. This may compromise product integrity until resolved.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Consumers and healthcare providers should treat this as a quality issue and use non-affected products until further guidance is issued.
Practical Guidance
How to identify if yours is affected
- Check the lot number on the container: A352318.
- Verify the NDC on the packaging: 75834-170-15.
- Confirm net weight: 15 oz (425 g).
- Note the product is manufactured in India for Nivagen Pharmaceuticals, Inc.
Where to find product info
FDA enforcement report page for D-0206-2026. Recall notices may also be distributed by Blossom Pharmaceuticals.
What timeline to expect
Refunds or replacements, if available, typically follow 4-6 weeks after recall confirmation.
If the manufacturer is unresponsive
- Document all contact attempts with Blossom Pharmaceuticals.
- Escalate to the FDA recall contact if the company is unresponsive.
- Consider filing a consumer complaint with CPSC if product misuse results in harm.
How to prevent similar issues
- Verify product origin and lot numbers when purchasing zinc oxide ointments.
- Buy from reputable retailers with clear recall policies.
- Keep product packaging until recall is resolved.
Documentation advice
Keep the product packaging, store receipt if available, and all recall notices and correspondence with the company.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: Nivagen Zinc Oxide. Product: Zinc Oxide Ointment USP 20% Skin Protectant. Net weight: 15 oz (425 g). NDC: 75834-170-15. Lot: A352318. Manufactured in: India. Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA. Quantity recalled: 912 containers. Distribution: USA Nationwide. Sold from: Not disclosed. Recall date: 2025-10-31. Status: ACTIVE. Price: Unknown.
Key Facts
- 912 containers recalled nationwide
- Manufactured in India for Nivagen Pharmaceuticals, Inc.
- Active recall status as of 2025-12-10
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.
