FDA Recalls CJC-1295 Injectable Due to Sterility Concerns

The US Food and Drug Administration (FDA) has issued a Class II drug recall for CJC-1295 Injectable, 6mg/15mg pre-filled syringes, manufactured and distributed by Thrive Health and Wellness, LLC, doing business as Thrive Health Solutions, based in Englewood, Colorado. A total of 60 syringes from two specific lots (H261968, expiring December 23, 2025, and H261358, expiring May 13, 2025) are affected by this recall. The recall was voluntarily initiated by the firm on May 21, 2025, with notification sent via email to consignees across the US.

The FDA classified this recall as Class II on June 20, 2025, indicating that use of the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote. The reason for the recall is a “lack of assurance of sterility,” raising significant concerns regarding patient safety, particularly given the injectable nature of the drug. A contaminated injectable poses risks of infection or other complications, especially in vulnerable patient populations.

CJC-1295 is a synthetic analog of growth hormone-releasing hormone (GHRH), often used in compounded pharmaceutical formulations for its purported anti-aging and growth hormone-boosting effects. It is commonly marketed for purposes such as weight loss, improved muscle mass, and energy enhancement, although it is not approved by the FDA for these uses. Pharmacists should exercise caution when encountering this product and inform patients accordingly, especially considering the unapproved status and recent safety concerns.