Zoladex Implant
FDA Recall NDC 70720-950

Latest: Class II · Status: Ongoing · Initiated Aug 31, 2026 · 1 enforcement report

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Zoladex (NDC 70720-950). A significant event, classified as Class II, was initiated on Aug 31, 2026 by Tersera Therapeutics Llc. The reported reason for this action was: "Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours."

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

August 2026 Class II Recall: Temperature Abuse

Recall Number
Class II Ongoing
Reason for Recall
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
Initiated
Aug 31, 2026
Reported
Oct 07, 2026
Quantity
296 cartons

Recall Profile & Regulatory Data

Event ID
99795
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
TerSera Therapeutics LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.
Batch or Lot Expiration Information
Lot# : YN0099, Exp 01/31/2028
Affected Packages Involved in this Recall
70720-950-36Zoladex

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.