FDA recall record

Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe recall — FDA D-0875-2026

Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

Class IIclassification
D-0875-2026official record ID
Oct 7, 2026report date

Recall record at a glance

Official recordD-0875-2026
CategoryDrug Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmTerSera Therapeutics LLC
Report dateOct 7, 2026
Recall initiation dateAug 31, 2026
Quantity296 cartons
LocationDeerfield, IL, United States

Official 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.

Why the product was recalled

Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

Distribution information

USA Nationwide

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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