Counterfeit Ozempic, compounded tirzepatide: indictment and recall

The Tampa indictment: counterfeit Ozempic from China

On September 29, 2026, the U.S. Department of Justice (DOJ) announced that a federal grand jury in the Middle District of Florida had charged two Indian nationals, Swapnadip Roy, 33, and Vicky Ramancha, 37, in a transnational counterfeit drug scheme¹. According to court documents, from at least July 2023 to April 2024 they obtained counterfeit Ozempic from unauthorized sources in China and sold it to U.S. distributors at deep discounts, with counterfeit packaging, package inserts, pen labels and needles meant to deceive buyers¹. Each is charged with one count of conspiracy to smuggle and to defraud the United States, three counts of smuggling and two counts of selling and holding counterfeit drugs for sale, with a maximum penalty of 71 years in prison¹.

Roy was arrested on an INTERPOL Red Notice, extradited from Italy and made his initial appearance in Tampa¹; Reuters reported that he pleaded not guilty and that Ramancha remains at large³. Both live in Dubai, according to ThePrint, which describes two buyers identified as "Company A" (Lakeland) and "Company B" (Sanford), a National Association of Boards of Pharmacy (NABP) audit of the first company's warehouse, and an internal warning that every unit carried the same serial number². The indictment states that "many units of the counterfeit Ozempic distributed by Roy and Ramancha did not include unique serial numbers," a requirement of the federal Drug Supply Chain Security Act (DSCSA)². An indictment is only an allegation: the defendants are presumed innocent unless proven guilty¹.

What FDA found in December 2023

DOJ says the scheme went on even after FDA seized some of the product in December 2023 and issued a public warning¹³. That December 21, 2023 notice asked wholesalers, pharmacies, prescribers and patients to check lot NAR0074 and serial number 430834149057 on Ozempic 1 mg²⁴. Beyond the drug itself, the needles, pen label, carton and professional and patient information were counterfeit; because the needles were fake, their sterility could not be confirmed⁴. FDA knew of five adverse events at the time, none serious and all consistent with known effects of the authentic product, and did not yet know the contents' identity or quality⁴. FDA notes that a counterfeit drug may contain too little, too much or none of the active ingredient, or other harmful ingredients⁹.

The other front: a compounded tirzepatide recall in North Carolina

While the criminal case moved forward, FDA's enforcement report posted two recalls from Apothecary Pharma LLC, a facility in Cary, North Carolina, on October 14, 2026⁵. The first (D-0036-2027) covers 22 vials of tirzepatide injection 18 mg/mL in a 4 mL sterile multi-dose vial (NDC 85091-001-18), lots AP-202622 through AP-202644 except AP-202626, with beyond-use dates from October 7 to November 26, 2026⁵. The second (D-0037-2027) covers one vial of NAD+ injection 200 mg/mL, 6 mL, lot AP-202647⁵. The reason for both is "Lack of Assurance of Sterility"; the firm started the recall by letter on September 24, with nationwide distribution, and FDA classified it Class II on October 8⁵⁶.

The notice reports no illnesses or injuries⁶. The Boston Globe noted that FDA did not say whether the injections were contaminated or what patients should do with their vials, and that neither the agency nor the company answered its questions⁷. Fox noted that Mounjaro and Zepbound, the approved tirzepatide products, are not affected, and that anyone with fever, redness, swelling or worsening pain after an affected injection should seek medical care⁶. We previously reviewed the salt, impurity and antibody problems of compounded GLP-1s in /pa/blog/glp1-magistrales-impurezas-anticuerpos/.

The 2025 warning letter: what inspectors saw

FDA inspected the plant from May 12 to 15, 2025 and sent warning letter 717972 on December 1, 2025⁸. The products it names include tirzepatide injection 10 mg/mL and semaglutide injection 2.5 mg/mL⁸. Among the observations, an operator "blocked first air by placing gloved hands directly over open sterile containers," another rested their arms on the hood's work surface during aseptic production, staff worked with exposed skin inside the ISO 5 area, and equipment or surfaces were "visibly rusty"⁸. FDA also objected to the lack of adequate smoke studies under dynamic conditions and to the firm calling dents and peeling paint "cosmetic"⁸. Fox stresses that the agency has not linked those findings to the current recall⁶.

What the reports and the literature show

FDA's page on unapproved GLP-1 drugs, current as of October 1, 2026, counts 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide as of May 31, 2026, and warns they are likely underreported because state-licensed pharmacies that are not outsourcing facilities do not have to report them⁹. It also describes events, some requiring hospitalization, that may be tied to dosing errors by patients or clinicians⁹. A review in the American Journal of Managed Care concluded that available compounded semaglutide products "may lack the quality controls" historically seen with compounding, with a risk of dosing errors, and that the worldwide market has seen fraudulent batches¹⁴; JAMA ran an analysis of the same question¹⁵. In the case literature, an 18-year-old woman in Belgium developed euglycemic ketoacidosis after using semaglutide bought online¹², and a Texas report described inflammatory facial nodules attributed to compounded tirzepatide¹³.

A checklist for physicians

• Check the lot and serial number of branded product against FDA alerts; units without a unique serial number are a red flag²⁴.
• Search FDA's enforcement report by firm and NDC before accepting a compounded vial⁵.
• Look up FDA warning letters to the supplying pharmacy or outsourcing facility⁸.
• Be wary of prices far below the authorized channel: the indictment describes sales to distributors at deep discounts¹.
• Report any suspected adverse event to MedWatch; FDA warns that compounded-product reports are undercounted⁹.