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

Nivagen zinc oxide ointment, 15 ounce size, recalled over manufacturing deviations

Blossom Pharmaceuticals is recalling 912 containers of Nivagen Zinc Oxide Ointment USP 20%, 15 oz, over current good manufacturing practice deviations.

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: Scored 2 because the record cites current good manufacturing practice deviations with no stated product defect or reported harm.

Plain-English summary

Nivagen Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, net weight 15 oz (425g), made in India and manufactured for Nivagen Pharmaceuticals, Inc. of Sacramento, California, under NDC 75834-170-15, is being recalled.

The reason given in the enforcement record is cGMP deviations.

The recall covers 912 containers from lot A352318. Distribution was nationwide in the USA. The FDA has classified the action as Class II.

The record cites manufacturing practice deviations without describing a specific product defect, and states no injuries. Customers should follow the firm's instructions.

The recalled product

Product
NIVAGEN ZINC OXIDE (ZINC OXIDE)
Brand
NIVAGEN ZINC OXIDE
Manufacturer
Blossom Pharmaceuticals
Category
Drug — Skin protectant
Hazard
  • cgmp-deviation
  • manufacturing-quality

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