"Popular Weight Loss Drugs Recalled: FDA Alerts 1,500 Vials"

Recall of Compounded GLP-1 Weight Loss Drugs Raises Concerns

In recent times, there has been a growing trend in the popularity of compounded GLP-1 drugs for weight loss, as they offer a more cost-effective alternative to well-known brand names. However, a recent recall of 1,476 vials of these drugs has shed light on the potential risks associated with substandard regulation of off-brand versions.

FDA Calls for Recall of Compounded GLP-1 Drugs

The U.S. Food and Drug Administration (FDA) issued a report on August 29, alerting the public to a recall of select compounded GLP-1 drugs from pharmacies. The Pennsylvania-based company Boothwyn Pharmacy LLC was found to have three batches of semaglutide-based drugs 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)

The recall also mentioned tirzepatide in the company's records.

Issues with Boothwyn Pharmacy LLC's Operations

An FDA report highlighted several concerns with Boothwyn Pharmacy LLC's oversight of drug manufacturing. It was found that the company had stored drugs under conditions that could render them harmful to health. In particular, the labeling on their semaglutide and tirzepatide formulations suggested freezing storage, despite a lack of stability studies supporting this condition.

Additionally, complaints were raised about the exposure of sterile drugs and materials to poor quality air, as well as the presence of dirty equipment and surfaces in the facility.

Critical Findings in Post-Release Testing

A subsequent notice from Boothwyn Pharmacy LLC revealed that an error was discovered during routine post-release testing between May and June 2025. The investigation found that specific lots of the company's compounded products were sub-potent, meaning they contained insufficient active ingredients to be fully effective.

The FDA classified this recall as a Class II incident, indicating that exposure to the affected products could lead to temporary or reversible health consequences, especially concerning for patients managing blood sugar levels.

Impact of Low Potency on Patient Health

Low potency in weight loss drugs can be particularly dangerous for patients relying on them to regulate blood sugar levels. Failure to manage blood sugar effectively can result in both short- and long-term complications, such as nerve damage, eye disease, and kidney damage.

Boothwyn Pharmacy LLC is urging consumers to check their products for identification based on Beyond Use Date (BUD) and specific codes printed on the labels. Any unused products should be returned to the manufacturer immediately.

Commitment to Quality Improvement

The company has expressed a commitment to addressing the issue by implementing enhanced safeguards to ensure the potency, sterility, and endotoxin testing results are compliant before products leave the facility. Boothwyn Pharmacy LLC is dedicated to rebuilding trust through transparency, accountability, and proactive measures.

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