FDA Recalls Nivagen Zinc Oxide Ointment Due to Manufacturing Deviations
Blossom Pharmaceuticals has recalled Nivagen Zinc Oxide Ointment nationwide due to current Good Manufacturing Practice (cGMP) deviations at the manufacturing facility. The recall affects 13,536 containers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is manufacturing compliance deviations without a specified contamination type, making this a voluntary precautionary recall typical of Score 2.
Plain-English summary
Blossom Pharmaceuticals is recalling Nivagen Zinc Oxide Ointment, a topical over-the-counter drug containing zinc oxide, distributed in 1-ounce (28.4g) containers. The product was distributed nationwide in the United States with NDC 75834-170-01 and related package codes, lot number A352405.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations identified at the manufacturing facility in Bardez, Goa, India. The firm voluntarily initiated the recall on October 31, 2025, following discovery of these compliance issues.
This recall affects 13,536 containers. Consumers who have purchased this product should stop using it and consult with a healthcare professional if they have questions or concerns about prior use of the recalled product.
The recalled product
- Product
- NIVAGEN ZINC OXIDE (ZINC OXIDE)
- Brand
- NIVAGEN ZINC OXIDE
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug — Topical OTC
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: A352405
Distribution
Distributed nationwide across the United States.
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- ModerateNIVAGEN zinc oxide ointment recalled for manufacturing deviations
FDA (Drugs) · 2025-12-10
- ModerateZinc oxide ointment recalled for manufacturing process deviations
FDA (Drugs) · 2025-12-10
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