Zinc Oxide 20% Ointment
FDA Recall NDC 69396-086
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Zinc Oxide 20% (NDC 69396-086). A significant event, classified as Class II, was initiated on Oct 31, 2025 by Trifecta Pharmaceuticals Usa. 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
33000 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
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
Batch or Lot Expiration Information
Lot# : A502404, Exp. Date 2/27; A502405, Exp. Date 2/27; AS02502, Exp. Date 2/28.
Affected Packages Involved in this Recall
69396-086-02Product
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.
