FDA-Drug2026-10-07Class IIPROCESSING DEFECT
Zoladex (goserelin) 3.6 mg implant recalled for temperature exposure during shipping
What this means
A shipment of Zoladex (goserelin) 3.6 mg implants was left in an unheated FedEx trailer in outdoor conditions for approximately 25.5 hours. This temperature exposure may have affected the medication's stability and effectiveness. The recall affects 296 cartons with lot number YN0099 (expiration 01/31/2028).
- If you have a Zoladex implant from lot YN0099 with expiration 01/31/2028, contact your healthcare provider immediately
- Do not use the medication until you have spoken with your doctor
- Your doctor will advise whether your dose needs to be replaced or reordered
The agency's original wording
Hazard
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
296 cartons
Manufactured in
520 Lake Cook Rd Ste 500, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0875-2026Want us to check the next one for you?
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