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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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 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.
There are no specific incidents or injuries reported related to this recall. The recall is classified as high risk due to potential safety implications.
Stop using the product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for further guidance. Notifications will be sent via letter.
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.
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