FDA Classifies Apothecary Pharma Injection Recall as Class II

A nationwide recall of compounded injectable medications from North Carolina-based Apothecary Pharma has received a Class II classification from the U.S. Food and Drug Administration (FDA) because the products' sterility cannot be assured. The recall, initiated September 24, covers 22 vials of tirzepatide and one vial of NAD+ injection, according to FDA information reported by Fox Business, USA TODAY and the Los Angeles Times.

The FDA's classification indicates that exposure could cause temporary or medically reversible health consequences, although the likelihood of serious harm is considered low. The agency updated the recall classification in October, with USA TODAY reporting the change on October 10.

The affected tirzepatide is a prescription medication containing the same active ingredient found in Mounjaro and Zepbound. The recalled product is a compounded formulation, not an FDA-approved, commercially manufactured version of those branded medications.

According to the FDA information cited by Fox Business, the tirzepatide comes in 18 mg/mL concentrations in 4 mL multidose vials. The affected lot numbers are AP-202622 through AP-202625 and AP-202627 through AP-202644, with beyond-use dates ranging from October 7 through November 26, 2026.

The recall also includes one NAD+ injection, a prescription product with a concentration of 200 mg/mL packaged in a 6 mL multidose vial. The affected lot is AP-202647, with a beyond-use date of October 13, 2026.

Apothecary Pharma initiated the voluntary recall and notified recipients by letter. The recall remained ongoing in the reports published October 19-21, 2026. The FDA notice did not identify any illnesses or injuries associated with the affected products.

The sterility concern follows a warning letter the FDA sent Apothecary Pharma in December 2025. According to the Los Angeles Times, the agency identified deficiencies during inspections conducted in September 2024 and January and May 2025, including problems involving sterile-drug production practices and product labeling.

The FDA described the manufacturing concerns in its warning letter as follows:

"serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk."

The warning letter also cited labeling deficiencies at the company's outsourcing facility in North Carolina. Some labels reportedly lacked active ingredient information, ingredient quantities, details for reporting adverse events and directions for use. The available reports do not establish a direct connection between those earlier findings and the current recall.

Apothecary Pharma's recall has also raised questions about how patients should handle affected medications. USA TODAY reported that a fulfillment service, NewLife Rx, sent some customers a notice relaying information attributed to Apothecary Pharma's team.

The notice characterized the issue as a "documentation issue" and stated that the recall was at the "retail level, which does not extend to patients or require them to stop using or return their medications."

However, USA TODAY reported that neither the FDA nor Apothecary Pharma had publicly clarified the discrepancy or provided a comprehensive public explanation of the products' safety. The outlet reported that it contacted both parties for comment on October 19 but had not received a response at publication.

The FDA's Class II designation does not mean that a recalled medication is entirely risk-free. The agency's classification describes a situation in which exposure may cause temporary or medically reversible consequences, while serious adverse health effects are considered unlikely.

Compounded medications are customized formulations prepared by pharmacies to meet specific patient needs. Unlike FDA-approved commercial drugs, compounded formulations do not undergo the same premarket FDA review for safety, effectiveness and quality.

Compounding pharmacies began producing versions of GLP-1 medications during shortages that started in 2022. According to USA TODAY and the Los Angeles Times, shortages of tirzepatide and semaglutide subsequently eased, but production of compounded versions continued, prompting increased regulatory scrutiny and legal disputes.

The recalled products are prescription injections. The FDA information cited in the published reports identifies the affected lots and beyond-use dates, while the recall remains ongoing and no associated illnesses or injuries have been reported.