NIVAGEN zinc oxide ointment recalled for manufacturing deviations
Blossom Pharmaceuticals voluntarily recalled 7,920 bottles of NIVAGEN Zinc Oxide Ointment (Lot A352505) distributed nationwide due to manufacturing practice deviations. The FDA classified the recall as Class II.
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 voluntary precautionary recall with no reported illnesses, injuries, or confirmed product defects. The recall is based on manufacturing practice deviations identified at the facility, rather than confirmed product contamination.
Plain-English summary
Blossom Pharmaceuticals initiated a voluntary recall of NIVAGEN Zinc Oxide Ointment USP (20% zinc oxide, 1 oz/28.4g bottles) distributed throughout the United States. The recall affects Lot #A352505, involving approximately 7,920 bottles.
The reason for the recall is current good manufacturing practice (cGMP) deviations identified at the manufacturing facility located in Bardez, Goa, India. The FDA has classified this as a Class II recall. The source documentation does not report any illnesses, injuries, or confirmed product defects associated with the recalled product.
Consumers who have purchased NIVAGEN Zinc Oxide Ointment should check their product's lot number to determine if it is affected by this recall. Those with the recalled lot should consult their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- NIVAGEN ZINC OXIDE (ZINC OXIDE)
- Brand
- NIVAGEN ZINC OXIDE
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug — Topical Ointment
- 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 #: A352505
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · NIVAGEN ZINC OXIDE
- ModerateFDA Recalls Nivagen Zinc Oxide Ointment Due to Manufacturing Deviations
FDA (Drugs) · 2025-12-10
- ModerateZinc oxide ointment recalled for manufacturing process deviations
FDA (Drugs) · 2025-12-10
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27