FDAClass IIDecember 10, 2025

Nivagen Pharmaceuticals recall: CGMP Deviations

Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen…

Why was Nivagen Pharmaceuticals recalled?

cGMP deviations

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: A352318

Product
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen…
Recalling firm
Blossom Pharmaceuticals
Quantity
912 containers
Distribution
USA Nationwide
Recall date
December 10, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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