Sterility concern puts GLP 1 drug distributed nationwide under active recall for 23 vials
Products included in the recall
The affected vials contain compounded versions of tirzepatide. It is the active ingredient in Eli Lilly’s Zepbound weight-loss drug and Mounjaro diabetes medication, but those brand-name products are not part of this recall.
Apothecary Pharma began the recall on September 24 and informed recipients by letter. The FDA says the recall remains ongoing.
FDA classifies the risk
On October 8, the FDA assigned the recall a Class II classification. The agency uses this category when a product may cause temporary health effects or problems that can be medically reversed, while the likelihood of serious harm is considered low.
What patients should do
People who obtained an affected product should stop using it and ask a pharmacist or health care provider for guidance. Compounded medicines are prepared by pharmacies or other authorized facilities for individual patient needs.
Unlike FDA-approved medicines, compounded drugs do not receive the same FDA assessment of safety, effectiveness and quality before marketing. Anyone who develops fever, redness, swelling or worsening pain after an affected injection should seek medical attention.
Key points
- The recall includes 23 vials of injectable medication distributed nationwide.
- The affected products are compounded tirzepatide, not Zepbound or Mounjaro.
- The FDA classified the action as Class II on October 8; it remains ongoing.
- Stop using affected products and seek advice from a pharmacist or health care provider.