Zinc Oxide Ointment
FDA Recall NDC 67777-223
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 (NDC 67777-223). A significant event, classified as Class II, was initiated on Oct 31, 2025 by Dynarex Corporation. 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
2592 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
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.
Batch or Lot Expiration Information
Lot# : A062434, Exp. Date 6/27 & A062449, Exp. Date 7/27
Affected Packages Involved in this Recall
67777-223-01Product
67777-223-11Product
67777-223-02Product
67777-223-03Product
67777-223-13Product
67777-223-04Product
67777-223-05Product
67777-223-06Product
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.
