HIGH

Nivagen Zinc Oxide Ointment Recalled Over cGMP Deviations

Nivagen Pharmaceuticals recalled 7,920 bottles of Zinc Oxide Ointment on October 31, 2025. The recall follows cGMP deviations that could impact product safety. Consumers should cease use immediately and consult healthcare providers for advice.

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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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.

The Hazard

The recall cites deviations from current Good Manufacturing Practices (cGMP), which may compromise the safety, quality, or efficacy of the product. Such deviations could result in ineffective treatment or adverse reactions.

Reported Incidents

There are no specific incidents or injuries reported related to this recall. The recall is classified as high risk due to potential safety implications.

What to Do

Stop using the product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for further guidance. Notifications will be sent via letter.

Contact Information

For more information, call Blossom Pharmaceuticals or visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0209-2026.

Key Facts

  • Recall date: October 31, 2025
  • Report date: December 10, 2025
  • Quantity recalled: 7,920 bottles
  • Manufactured in India

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: A352505
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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