Zoladex (Goserelin) Implant Recalled Due to Improper Temperature Regulation

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Zoladex (goserelin) implant, 3.6 mg. The affected batch has been identified as Lot YN0099 (expires January 2028), containing 296 cartons.
• The recall was initiated by TerSera Therapeutics, LLC due to improper temperature regulation, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Goserelin is used to treat prostate cancer, breast cancer, and endometriosis.

The FDA has issued a Class II recall for Zoladex (goserelin) implant, 3.6 mg, affecting 296 cartons. This product is manufactured by AstraZeneca UK, Ltd. It is being recalled by TerSera Therapeutics, LLC based in Deerfield, Illinois. The recall was initiated on August 31, 2026, and received a Class II classification on September 28, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated after the firm discovered the product had been left in a non-temperature-controlled trailer for over 24 hours. This issue affects Lot YN0099, which will expire in January 2027. TerSera Therapeutics sent out a public notice via letter; no press release has been issued for this recall.

Goserelin is a hormone that suppresses the production of sex hormones. It is used to treat prostate cancer, breast cancer, and endometriosis. It can also be used to thin the uterine lining before surgery. Pharmacists should identify and quarantine Lot YN0099, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 7, 2026. Accessed October 7, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222501