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.
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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Nivagen Zinc Oxide Ointment is used for skin protection and is commonly purchased for its soothing and barrier properties for diaper rash and minor skin irritations.
The cGMP deviations may result in inconsistencies in the product's formulation or contamination, posing risks to consumers.
This recall is not part of a broader industry pattern.
Consumers may face inconvenience and potential health risks if they continue to use the affected ointment.
The lot number can typically be found on the bottom of the tube or box packaging.
Refund processing may take 4-6 weeks.
Keep receipts, correspondence with the manufacturer, and take photos of the product for your records.
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.
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