Over 600,000 bottles of the blood pressure medication ramipril have been recalled throughout the United States due to worries regarding possible contamination.
The FDA initiated the recall after finding that the medication included components sourced from a manufacturing facility in India that had not been inspected or approved.
What is Ramipril?
Ramipril is a commonly prescribed medication, utilized by over 2.4 million Americans each year, to control high blood pressure by relaxing blood vessels. Although no adverse events have been reported to date, the FDA warns that the capsules may present a contamination risk, although the overall risk to public health is deemed low.
Details of the Recall
The recall pertains to bottles of ramipril manufactured by Lupin Pharmaceuticals, an Indian firm. The affected capsules are offered in three different strengths:
2.5 mg
5 mg
10 mg
The bottles contain either 90, 100, or 500 capsules and have expiration dates that extend to July 2026. Initially, the recall focused on the 5mg and 10mg strengths, but on November 19, the 2.5mg dosage was included.
FDA Findings
The FDA disclosed that the active pharmaceutical ingredient (API) contained in the capsules was obtained from a manufacturer located in Goa, India, which had not received appropriate inspection or approval. This led to a Class II recall, indicating a low likelihood of serious injury or death while recognizing the possibility of adverse effects.
What Should Consumers Do?
Dispose of or return the product: Consumers are recommended to either throw away the affected bottles or return them to the retailer for a complete refund.
Consult a doctor: Individuals taking ramipril should contact their healthcare provider for advice on transitioning to different medications or acquiring new prescriptions.
FDA resource: A comprehensive list of the affected bottles can be found on the FDA website.
Broader Concerns with Indian-Made Drugs
This occurrence is the most recent in a series of recalls associated with medications produced in India:
Cinacalcet Recall: Just weeks earlier, Dr. Reddy’s Laboratories recalled more than 330,000 bottles of cinacalcet tablets, which are used to treat hyperparathyroidism, due to the detection of cancer-causing impurities.
Contaminated Eye Drops: In 2022, eye drops manufactured in India and marketed under brands such as EzriCare Artificial Tears triggered a multi-state health crisis. More than 80 infections, vision impairment, and four fatalities from sepsis were attributed to bacterial contamination resulting from insufficient microbial testing and inadequate preservatives at the Global Pharma Healthcare facility.
