The hazard may be of heightened concern for a certain group of users, but a wider audience may learn a storage method that's not recommended.
Compounded GLP-1 drugs have surged in popularity, thanks in large part to the often prohibitive costs of brands whose names are so well known. Today, another nuance of injectable weigh loss meds warrants attention: substandard regulation of off-brand versions can lead to subprime products and possible health complications, as a recent recall affecting 1,476 vials suggests.
The U.S. Food and Drug Administration (FDA) published an August 29 report that the Pennsylvania-based company Boothwyn Pharmacy LLC had been called to pull select compounded GLP-1s from pharmacies. Three batches of the firm’s semaglutide-based drugs, prescribed largely off-label to manage overweight and obesity, were implicated in the recall:
- Semaglutide, 2.5 mg/mL injection, 2 mL (642 vials)
- Semaglutide, 2.5 mg/mL injection, 0.8 mL (186 vials)
- Semaglutide, 2.5 mg/mL injection, 4 mL (648 vials)
Tirzepatide is also mentioned in the records.
An FDA report detailing the company’s oversight notes that several drugs made by the company, not limited to the semaglutide injections, were “held under environmental conditions whereby it may have been rendered injurious to health. Specifically, the labels on your Semaglutide and Tirzepatide drug formulations state ‘store frozen’ when no studies have been conducted to indicate these drugs are stable under this storage condition. The labeling for the approved drug products states, ‘Do not freeze and do not use if it has been frozen,’” the FDA wrote.
That report noted additional complaints, including that sterile drugs and materials were exposed to poor quality air, as well as “porous, particle generating, or visibly dirty equipment or surfaces.”
Further, while the FDA had first issued an advisory on July 9, a subsequent August 4 notice released by the recalling firm via the California State of Board Pharmacy notified customers that an error was discovered during “routine post-release testing,” which is said to have occurred between May and June 2025. This Corrective and Preventive Actions (CAPA) investigation found that specific lots of the company’s compounded products were sub-potent, meaning they contained too little active ingredient to be fully effective.
The FDA’s August 29 update has designated this recall a Class II incident, suggesting that exposure to the affected products could “cause temporary or medically reversible health consequences,” but, according to the FDA’s recall classification system, is unlikely to cause death. One critical note: Low potency could be especially dangerous for patients using the product to regulate blood sugar, rather than weight. According to the Cleveland Clinic, failure to manage blood sugar can result in both short- and long-term complications, including nerve damage, eye disease, kidney damage, and more.
The company is now encouraging patients to immediately examine their products, discontinue use, and return any unused product to the manufacturer. Consumers may identify the products by their Beyond Use Date (BUD), which is July 18, 2025, or the following codes, which are printed on the labels: 03202025@2, 03202025@3, 03202025@4,03202025@5, 03202025@6, 03202025@7, 03202025@8, 03202025@9.
“Boothwyn takes this matter seriously and [is] committed to earning and maintaining trust in our operations through transparency, accountability, and action,” company representatives are quoted as having stated. “As part of our commitment to quality, we have already implemented enhanced safeguards, including ensuring all required potency, sterility, and endotoxin testing results are received by the pharmacy, and passing, before any product leaves our facility.”
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