GLP-1 injections recalled nationwide over sterility concerns, FDA says

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1. 2h ago

   GLP-1 Injections Recalled Nationwide Over Sterility Concerns

   Federal health regulators announced a nationwide recall for compounded GLP-1 tirzepatide and NAD+ injections distributed by Apothecary Pharma. The Food and Drug Administration flagged the products because their sterility cannot be assured, prompting a Class II risk classification for the medication. Patients across the United States are urged to check specific lot numbers and expiration dates to determine if their weight-loss treatment is affected. The action follows prior warnings issued to the company regarding its manufacturing practices.

   Why it matters

   Compounded versions of popular weight-loss and diabetes treatments have surged in popularity amid widespread brand-name drug shortages. However, compounded medications lack the rigorous FDA pre-market approval process required for manufactured drugs, making oversight and sterility critical issues. The Food and Drug Administration previously warned Apothecary Pharma about production practices before initiating this latest nationwide safety action.

   What is confirmed

   • Apothecary Pharma is recalling compounded GLP-1 and NAD+ injections nationwide over sterility concerns.
   • The Food and Drug Administration previously warned the company about production practices.
   • The recall includes 22 lots of compounded tirzepatide injections and one lot of NAD+ injection.
   • The recall has been classified as a Class II risk.

   Still unconfirmed

   • A total of 23 vials or 22 vials of injectable drugs were recalled depending on the specific reporting source count.

   What to watch next

   • Updates from the FDA regarding adverse event reports tied to the recalled lots
   • Further regulatory enforcement actions against Apothecary Pharma
   Sources used for this update (16)

   1. nypost.com — New York Post – Breaking News, Top Headlines, Photos & Videos
   2. www.foxbusiness.com — GLOBAL ECONOMY - Fox Business
   3. USA Today — GLP-1 injections recalled nationwide. See affected products
   4. MassLive — GLP-1 recall: Mounjaro, Zepbound ingredient risk raised to second-highest level
   5. Fox Business — GLP-1 injections recalled nationwide over sterility concerns, FDA says
   6. Democrat and Chronicle — GLP-1 injections recalled nationwide: See affected lots and what to know
   7. The Times of India — GLP-1 injections recalled across the US over sterility concerns: How contaminated vials and dosing errors can put patients at risk
   8. www.foxbusiness.com — GLP-1 injections recalled nationwide over sterility concerns, FDA says | Fox Business
   9. www.unilad.com — GLP-1 medication Tirzepatide recalled over safety and sterility concerns
   10. nypost.com — GLP-1 injections recalled nationwide over concerning reason
   11. www.fox5ny.com — FDA recalls GLP-1 drug, other injectable medication over sterility concerns | FOX 5 New York
   12. wrrv.com — Compounded Tirzepatide Injection Recall, Lot Numbers Affected - 92.7/96.9 WRRV
   confidence 95%