REGULATORY INTELLIGENCE·Recall
FDA Initiates Class III Recall for Qualgen's Testosterone 200 mg Pellets Over Labeling Errors
Qualgen, LLC initiated a Class III recall (D-0517-2025) for 2,832 vials of Testosterone 200 mg Pellets due to incorrect lot numbers on labels, stemming from a printing error. This nationwide recall, ongoing since June 16, 2025, necessitates immediate action from distributors and healthcare providers to verify product authenticity and ensure patient safety, impacting supply chain integrity for compounded hormone therapies.
90-Day Activity
Qualgen, LLCEsokalli Testosterone Booster Oral Dissolving Film
PSPriya Subramaniam· Intelligence Analyst2025-07-23