Nivagen Zinc Oxide Ointment Recall 912 Containers Over cGMP Deviations (2025)
Nivagen Zinc Oxide Ointment 20% skin protectant, manufactured in India for Nivagen Pharmaceuticals and distributed nationwide in the USA, is recalled. The recall covers 912 containers. The defect cited is cGMP deviations. Consumers and healthcare providers should stop using the product and follow guidance from Blossom Pharmaceuticals or a healthcare professional.
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.
The Hazard
The recall is based on cGMP deviations. Potential impact includes compromised product quality or safety due to manufacturing process issues. Consumers should not use affected lots until recall is resolved.
What to Do
1 Stop using the product. 2 Contact Blossom Pharmaceuticals or your healthcare provider for guidance. 3 Monitor for recall updates. 4 Follow the instructions on the recall notification.
Contact Information
Recall page: FDA enforcement report for D-0206-2026. Remedial contact: Blossom Pharmaceuticals or your healthcare provider. Note: Specific phone or mailing address not provided in the summary.