GLP-1 drug distributed nationwide under recall

A nationwide recall has been issued for 23 vials of injectable medication, including a popular GLP-1 weight-loss drug, over concerns that the products may not be sterile.North Carolina-based Apothecary Pharma voluntarily recalled 22 vials of compounded tirzepatide and one vial of NAD+ injection, according to the Food and Drug Administration.The FDA classified the recall as Class II on October 8, meaning the products could cause temporary or medically reversible health problems, though the risk of serious harm is considered low. The recall is still ongoing, according to the agency.Tirzepatide is the active ingredient in Eli Lilly's weight-loss drug Zepbound and diabetes medication Mounjaro. The recalled products, however, are compounded versions of the drug, not the brand-name medications themselves.The recall covers specific batches of the prescription injections distributed nationwide. Anyone who has purchased these products should check their vial labels for the following details.Tirzepatide is the active ingredient in Eli Lilly’s weight-loss drug Zepbound and diabetes medication Mounjaro, but the recalled products are compounded versions, not the brand-name drugs themselves (PA)The affected products are:Tirzepatide injectionStrength: 18 mg/mLVial size: 4 mL multidose vialNational Drug Code (NDC): 85091-001-18Recalled lot numbers: AP-202622, AP-202623, AP-202624, AP-202625 and AP-202627 through AP-202644Beyond-use dates: October 7 to November 26, 2026NAD+ injectionStrength: 200 mg/mLVial size: 6 mL multidose vialNational Drug Code (NDC): 85091-011-06Recalled lot number: AP-202647Beyond-use date: October 13, 2026Apothecary Pharma launched the recall on September 24 and notified recipients by letter. The action comes after the FDA sent the company a warning letter in December over serious problems with its sterile drug manufacturing practices. The agency said the deficiencies posed risks to patients, though it has not confirmed whether they are directly related to the current recall.Compounded medications are made by pharmacies or other authorized facilities to meet individual patients' needs. Unlike FDA-approved drugs, they do not undergo the same FDA review for safety, effectiveness and quality before being marketed.Anyone with a recalled product should stop using it and contact their pharmacist or health care provider for advice.Those who develop a fever, redness, swelling or worsening pain after receiving an affected injection should seek medical attention.The FDA has not reported any illnesses or injuries linked to the recalled products.