Nivagen Pharmaceuticals recalled 13,536 containers of zinc oxide ointment on October 31, 2025. The recall follows deviations from current Good Manufacturing Practices (cGMP). Consumers must stop using the product immediately and contact healthcare providers for guidance.
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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The recalled product is Nivagen Zinc Oxide Ointment, net weight 1 oz. (28.4g). The lot number affected is A352405. It was distributed nationwide in the USA.
The recall stems from deviations in manufacturing practices that do not meet federal regulations. These deviations can lead to inconsistent product quality and potential harm to consumers.
There have been no reported injuries or incidents associated with the use of this product at this time.
Stop using the zinc oxide ointment immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance on the next steps.
For more information, consumers can visit the FDA recall page or contact Blossom Pharmaceuticals directly.
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