CLASS II ONGOING Drug recall · Reported 7 Oct 2026 · FDA Enforcement Report
Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe recalled
TerSera Therapeutics is recalling Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe, distributed nationwide in the US. The recall was initiated on 31 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0875-2026
- FDA event ID
- 99795
- Recalling firm
- TerSera Therapeutics, Deerfield, IL
- Brand
- Zoladex
- Manufacturer
- TerSera Therapeutics LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Aug 2026
- FDA classified
- 28 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
Timeline
| 31 Aug 2026 | Recall initiated by company | |
| 28 Sep 2026 | Classified by FDA | +28 days |
| 7 Oct 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
Which lots are affected?
Lot#: YN0099, Exp 01/31/2028
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.