Sermorelin Recalled Due to Lack of Process Control

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for sermorelin, 1 mg/mL. The affected batch has been identified as Lot SER-081726-1-10 (expiring October 2026), containing 7 vials.
• The recall was initiated by Houston Rx, LLC due to a lack of process control, 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.
• Sermorelin is used to increase growth hormone production in children.

The FDA has issued a Class II recall for sermorelin, 1 mg/mL, affecting 7 vials. Houston Rx, LLC, based in Houston, Texas, manufactured the product and initiated the recall on September 25, 2026. The FDA assigned a Class II classification on October 13, 2026, which 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 due to a lack of process control in the product’s manufacturing. This issue affects Lot SER-081726-1-10, which will expire in October 2026. Houston Rx sent out public notices via email, letter, fax, telephone, and personal visit; no press release has been issued for this recall.

Sermorelin is a prescription medication used to increase growth hormone production in children who are behind in growth development. Pharmacists should identify and quarantine Lot SER-081726-1-10, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 21, 2026. Accessed October 21, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=223082