Peru Recalls Injectable Solution and Medical Supplies Due to Quality Concerns

The Peruvian health authority, Digemid, has ordered the recall and destruction of several health products, including the BUPIDEX-HG 0.5% injectable solution, due to quality control failures that pose potential risks to patient health. The recalls encompass a range of products, from injectable medications to surgical supplies and medical devices.

BUPIDEX-HG 0.5% Injectable Solution Recall

Digemid initiated the recall of lot ML25391 of the BUPIDEX-HG 0.5% (Bupivacaine) injectable solution, manufactured in India and packaged in 20ml vials. The decision stemmed from the detection of visible particles within the solution, violating required quality standards for safe patient use. Infobae reported the recall on February 20, 2026.

Additional Recalled Products

Beyond the injectable solution, Digemid also ordered the removal of the following products:

• Surgical Gauze Pads: Lot 2100064 of L & M brand medium surgical gauze pads (Type VI – Sterile, 15 cm x 50 cm) were recalled due to the presence of foreign material and brown spots, potentially compromising sterility.
• Three-Way Stopcock: Lot 2K081 of OnePlus brand three-way stopcocks without extension tubes were recalled due to imperfections and sharp edges, increasing the risk of injury during clinical use.
• Intravenous Cannula: Lot 052402 of BIO ON 22G x 1” intravenous cannulas were recalled due to imperfections, foreign particles, and uneven edges on the catheter tip and introducer needle, posing risks of injury and infection.

Consumer Protection and Reporting

Digemid encourages citizens to report any dangerous products and to consult the list of active alerts through the Indecopi Consumption Alert System. A dedicated telephone line, (01) 631 4300, is available for inquiries regarding these recalls and the safety of pharmaceutical products. Indecopi provides further details on the Bupidex-HG recall (A4161).

Digemid’s Role in Public Health

The General Directorate of Medicines, Supplies and Drugs (Digemid) is the Peruvian Ministry of Health agency responsible for regulating, supervising, and monitoring the quality, safety, and effectiveness of medicines, medical devices, and health products within the country. Its functions include authorizing registrations, controlling imports, and protecting public health against associated risks.