Rachel V Thomas

Health and Me

Mounjaro, Zepbound Ingredient Recalled In US Over Sterility Concerns

More than 20 vials of compounded <span>tirzepatide</span>, a GLP-1 medication containing the same active ingredient as Eli Lilly’s <span>Mounjaro</span> and <span>Zepbound</span>, have been recalled in the US over sterility concerns, according to the Food and Drug Administration (<span>FDA</span>).

The recall, issued by <span>Apothecary Pharma</span>, also includes a vial of NAD+ injection.

The FDA classified the recall as Class II, meaning the affected products could cause temporary or medically reversible adverse health consequences, while the likelihood of serious harm is considered low.

The recall follows a December 2025 FDA warning letter to <span>Apothecary</span> Pharma, which cited serious deficiencies in the North Carolina company’s sterile drug production practices.

The recalled injections are compounded versions of tirzepatide. Unlike FDA-approved, brand-name medications, compounded drugs are custom-prepared by pharmacies to meet specific patient needs.

<h2>Which Compounded GLP-1 Injections Were Recalled?</h2>

<strong>Also read: </strong><a href="https://www.healthandme.com/health-news/us-fda-may-allow-pharmacies-to-make-unapproved-peptide-injections-what-are-the-safety-concerns-article-156349135" data-type="tilCustomLink">US FDA May Allow Pharmacies To Make Unapproved Peptide Injections: What Are the Safety Concerns?</a>

The affected tirzepatide product is a prescription injection with a concentration of 18 mg/mL, supplied in a 4 mL multidose vial. Its National Drug Code (NDC) number is 85091-001-18.

The recalled lot numbers are AP-202622 through AP-202625 and AP-202627 through AP-202644. The products have beyond-use dates ranging from October 7 to November 26, 2026.

The recall also includes one vial of NAD+ injection.

<h2>What Should You Do If You Have a Recalled Vial?</h2>

The FDA and Apothecary Pharma have not issued a public statement clarifying what patients should do with the affected vials. Some customers have reported receiving requests through their prescribers to return or dispose of the products or contact the manufacturer directly.

NewLife Rx, a pharmaceutical fulfillment service that distributed some of the recalled vials, reportedly told certain customers that Apothecary had described the recall as a documentation issue.

According to a notice reviewed by USA TODAY, the recall was conducted at the retail level and did not extend to patients or require them to stop using or return their medications.

However, neither the FDA nor Apothecary Pharma has publicly clarified the reason for the recall or the safety of the affected products.

Although a Class II classification indicates a relatively low likelihood of serious harm, it does not mean a product is entirely risk-free.

If you have an affected lot, consult your prescriber or healthcare provider before using it again and follow their instructions.

<strong>Read More: </strong><a href="https://www.healthandme.com/health-news/retatrutide-driving-peptide-linked-emergency-hospital-visits-in-australia-what-are-the-risks-article-156365185" data-type="tilCustomLink">Retatrutide Driving Peptide-Linked Emergency Hospital Admissions In Australia: What Are The Risks?</a>

<h2>What Are the Risks of Compounded GLP-1 Drugs?</h2>

A compounded drug is a medication prepared by a compounding pharmacy to meet an individual patient's specific medical needs. This may include removing an allergen, adjusting a dosage, or preparing a formulation that is not commercially available.

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While these medications can serve specific medical needs, they are not FDA-approved in the same way as branded drugs. The FDA does not review compounded formulations for safety, effectiveness, and quality before they are marketed.

Demand for GLP-1 medications for weight loss skyrocketed worldwide between 2022 and 2025, leading to shortages of semaglutide and tirzepatide.

During these shortages, compounding pharmacies were legally allowed under specific circumstances to prepare several versions of these medications.

Many patients turned to compounded GLP-1s because they were often affordable, available, and easier to buy online.

<strong>Potential risks of compounded GLP-1 drugs include:</strong>

<ul><li>Inaccurate Dosing</li><li>Sterility Concerns</li><li>Different Ingredients</li><li>Limited Safety Data</li><li>Counterfeit or <span rel="noindex">Unregulated Products</span></li></ul>

Health Conditions A-Z

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Mounjaro

zepbound

apothecary pharma

eli lillys mounjaro

tirzepatide

GLP 1 drug

mounjaro side effects

apothecary

unregulated products

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More than 20 vials of compounded tirzepatide, a GLP-1 medication containing the same active ingredient as Eli Lilly’s Mounjaro and Zepbound, have been recalled in the US over sterility concerns, according to the Food and Drug Administration (FDA).The recall, issued by Apothecary Pharma, also includes a vial of NAD+ injection.The FDA classified the recall as Class II, meaning the affected products could cause temporary or medically reversible adverse health consequences, while the likelihood of serious harm is considered low.The recall follows a December 2025 FDA warning letter to Apothecary Pharma, which cited serious deficiencies in the North Carolina company’s sterile drug production practices.The recalled injections are compounded versions of tirzepatide. Unlike FDA-approved, brand-name medications, compounded drugs are custom-prepared by pharmacies to meet specific patient needs.Which Compounded GLP-1 Injections Were Recalled?Also read: US FDA May Allow Pharmacies To Make Unapproved Peptide Injections: What Are the Safety Concerns?The affected tirzepatide product is a prescription injection with a concentration of 18 mg/mL, supplied in a 4 mL multidose vial. Its National Drug Code (NDC) number is 85091-001-18.The recalled lot numbers are AP-202622 through AP-202625 and AP-202627 through AP-202644. The products have beyond-use dates ranging from October 7 to November 26, 2026.The recall also includes one vial of NAD+ injection.What Should You Do If You Have a Recalled Vial?The FDA and Apothecary Pharma have not issued a public statement clarifying what patients should do with the affected vials. Some customers have reported receiving requests through their prescribers to return or dispose of the products or contact the manufacturer directly.NewLife Rx, a pharmaceutical fulfillment service that distributed some of the recalled vials, reportedly told certain customers that Apothecary had described the recall as a documentation issue.According to a notice reviewed by USA TODAY, the recall was conducted at the retail level and did not extend to patients or require them to stop using or return their medications.However, neither the FDA nor Apothecary Pharma has publicly clarified the reason for the recall or the safety of the affected products.Although a Class II classification indicates a relatively low likelihood of serious harm, it does not mean a product is entirely risk-free.If you have an affected lot, consult your prescriber or healthcare provider before using it again and follow their instructions.Read More: Retatrutide Driving Peptide-Linked Emergency Hospital Admissions In Australia: What Are The Risks?What Are the Risks of Compounded GLP-1 Drugs?A compounded drug is a medication prepared by a compounding pharmacy to meet an individual patient's specific medical needs. This may include removing an allergen, adjusting a dosage, or preparing a formulation that is not commercially available.   While these medications can serve specific medical needs, they are not FDA-approved in the same way as branded drugs. The FDA does not review compounded formulations for safety, effectiveness, and quality before they are marketed.Demand for GLP-1 medications for weight loss skyrocketed worldwide between 2022 and 2025, leading to shortages of semaglutide and tirzepatide.During these shortages, compounding pharmacies were legally allowed under specific circumstances to prepare several versions of these medications.Many patients turned to compounded GLP-1s because they were often affordable, available, and easier to buy online. Potential risks of compounded GLP-1 drugs include:Inaccurate DosingSterility ConcernsDifferent IngredientsLimited Safety DataCounterfeit or Unregulated Products

glp-1 drug mounjaro, zepbound ingredient recalled in us over sterility concerns

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