Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera the
Summary
The FDA issued a Class II for Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton by TerSera Therapeutics LLC. Reason: Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours..
Details
Source
Drug Recall
External ID
D-0875-2026
Action Date
2026-10-07
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot#: YN0099, Exp 01/31/2028
Quantity Affected: 296 cartons
Reason for Recall
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-31
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 23 drug recalls issued in the same week, part of 40 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TerSera Therapeutics LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TerSera Therapeutics LLC have FDA actions?
This is the only FDA action we have on record for TerSera Therapeutics LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0875-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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