The Recall Desk
ModerateFDA (Drugs)·D-0206-2026·Announced 2025-12-10

Zinc oxide ointment recalled for manufacturing process deviations

Blossom Pharmaceuticals is recalling NIVAGEN ZINC OXIDE ointment (Lot #A352318) nationwide due to manufacturing process deviations. Consumers should stop using the affected product.

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: FDA Class II recall with no reported illnesses, injuries, or adverse events. The recall is voluntary and precautionary, based on manufacturing process deviations that present theoretical risk but no documented harm.

Plain-English summary

Blossom Pharmaceuticals is recalling NIVAGEN ZINC OXIDE (Zinc Oxide Ointment USP, 20% Skin Protectant) due to cGMP (current Good Manufacturing Practice) deviations identified during manufacturing. The recalled product is available in 15 oz containers with Lot #A352318.

The recall affects 912 containers distributed nationwide in the United States. The product was manufactured in India and is identified by NDC 75834-170-15. This is a voluntary recall initiated by the firm.

Consumers should stop using affected product with the recalled lot number. Those with questions about whether their product is affected should contact Blossom Pharmaceuticals with their lot number.

The recalled product

Product
NIVAGEN ZINC OXIDE (ZINC OXIDE)
Brand
NIVAGEN ZINC OXIDE
Manufacturer
Blossom Pharmaceuticals
Category
Drug — Topical Ointment
Hazard
  • manufacturing-defect

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 #: A352318

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · NIVAGEN ZINC OXIDE

Same category