Nivagen Zinc Oxide Ointment
FDA Recall NDC 75834-170
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Nivagen Zinc Oxide (NDC 75834-170). A significant event, classified as Class II, was initiated on Oct 31, 2025 by Nivagen Pharmaceuticals, Inc.. The reported reason for this action was: "cGMP deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP deviations
Oct 31, 2025
Dec 10, 2025
912 containers
Recall Profile & Regulatory Data
Event ID
97935
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Blossom Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.
Batch or Lot Expiration Information
Lot# : A352318
Affected Packages Involved in this Recall
75834-170-01Product
75834-170-02Product
75834-170-15Product
Class II Ongoing
cGMP deviations
Oct 31, 2025
Dec 10, 2025
7920 bottles
Recall Profile & Regulatory Data
Event ID
97935
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Blossom Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
Batch or Lot Expiration Information
Lot# : A352505
Affected Packages Involved in this Recall
75834-170-01Product
75834-170-02Product
75834-170-15Product
Class II Ongoing
cGMP deviations
Oct 31, 2025
Dec 10, 2025
13536 containers
Recall Profile & Regulatory Data
Event ID
97935
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Blossom Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
Batch or Lot Expiration Information
Lot# : A352405
Affected Packages Involved in this Recall
75834-170-01Product
75834-170-02Product
75834-170-15Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
