Goserelin Implant Recall: Zoladex 3.6 mg
The FDA is recalling TerSera Therapeutics LLC's Zoladex (goserelin) implant, a 3.6 mg Rx-only device sold as a single-use syringe packaged in a carton. The recall involves 296 cartons distributed nationwide in the USA, Lot YN0099 with expiration 01/31/2028. The reason is temperature abuse: the product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for about 25.5 hours.
| Brand | TerSera Therapeutics LLC |
|---|---|
| Product | 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. |
| Reason | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours. |
| Severity | moderate |
| Units affected | 296 |
| Distribution | USA Nationwide |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any Zoladex implant from Lot YN0099; check packaging for the lot number.
- Contact your healthcare provider or the pharmacy that supplied the product for instructions on replacement or return.
- Preserve the product packaging and any documentation; report any adverse effects to your healthcare provider and the FDA MedWatch program if applicable.
- Follow disposal or return instructions provided by your clinician or the supplier.
How to identify the recalled item
| Lot / date codes | Lot#: YN0099, Exp 01/31/2028 |
|---|---|
| Lot / date codes | Lot#: YN0099, Exp 01/31/2028 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.