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.
cGMP deviations
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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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.
cGMP deviations indicate manufacturing quality control issues that could affect product safety or potency. This may compromise product integrity until resolved.
This recall is not described as part of a broader industry pattern in the provided data.
Consumers and healthcare providers should treat this as a quality issue and use non-affected products until further guidance is issued.
FDA enforcement report page for D-0206-2026. Recall notices may also be distributed by Blossom Pharmaceuticals.
Refunds or replacements, if available, typically follow 4-6 weeks after recall confirmation.
Keep the product packaging, store receipt if available, and all recall notices and correspondence with the company.
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.
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