Estradiol Gel
FDA Recall NDC 70954-533
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 Estradiol (NDC 70954-533). A significant event, classified as Class II, was initiated on May 12, 2026 by Ani Pharmaceuticals, Inc.. The reported reason for this action was: "Defective Container; packets were found to be either empty or partially full."
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
May 2026 Class II Recall: Defective Container; packets were found to be either empty or partially full.
Recall Number
Class II Ongoing
Defective Container; packets were found to be either empty or partially full.
May 12, 2026
May 27, 2026
3964 Cartons
Recall Profile & Regulatory Data
Event ID
98947
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ANI Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Batch or Lot Expiration Information
Lot# Lot M251109, exp Nov 2027
Affected Packages Involved in this Recall
70954-531-10Product
70954-531-20Product
70954-532-10Product
70954-532-20Product
70954-533-10Product
70954-533-20Product
70954-534-10Product
70954-534-20Product
70954-530-10Product
70954-530-20Product
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.
