More than 600,000 bottles of a blood pressure drug sold across the US have been recalled over fears they could be contaminated.
Ramipril is prescribed to more than 2.4million Americans every year and used to lower blood pressure by causing blood vessels to widen.
But the FDA has issued a recall because the drugs were made with ingredients from a vendor in India whose factory had not been inspected or approved by the agency.
This raises concerns that the capsules could be at risk of contamination.
But the overall risk to the public is low, the agency said, and there have been no adverse events reported from consuming the drugs to date.
The recall affects capsules of the drug made by Indian company Lupin Pharmaceuticals and sold in strengths of 2.5 milligrams (mg), 5mg and 10mg.
They are in bottles of either 90, 100 or 500 capsules, and have best before dates up to July 2026.
The capsules were manufactured in Goa, India, and the recall was launched on October 23 for the 10mg and 5mg strengths. This was expanded to include 2.5mg doses on November 19.
An FDA inspection revealed that an active pharmaceutical ingredient (API), the main ingredient in a drug that causes its effect, was made by a separate manufacturer not approved by the agency.
The recall is categorized as Class II, which is issued when a product has a low chance of causing serious injuries or death.
A Class I action is when there is a reasonable probability of injury.
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A total of 350,000 bottles of the 10mg capsules have been recalled, as well as 146,000 bottles of the 5mg capsules and 110,000 bottles of the 2.5mg.
The bottles were sold in at least 30 vendors nationwide, who have not been named.
Customers are advised to throw away the bottles or return them to sellers for a full refund.
They are also advised to contact their doctors to ask about next steps and new prescriptions.
A full list of the bottles that have been recalled were revealed on the FDA website.
Lupin Pharmaceuticals did not respond to a DailyMail.com request for comment.
It comes about two weeks after Indian drugmaker Dr Reddy’s Laboratories recalled 331,500 bottles of medical tablets due to the presence of a cancer-causing material.
The cinacalcet tablets were used to treat hyperparathyroidism, a common condition diagnosed in 100,000 people every year where hormone problems cause high levels of calcium in the blood.
But were recalled after testing by the FDA showed they were contaminated with high levels of a nitrosamine-related impurity, which has been linked to cancer.
The company did not reveal where the tablets were manufactured, and it was a Class II recall.
Last year, over-the-counter eye drops made in India were at the center of a multi-state recall after they were found to be contaminated with a bacteria that ‘melted eyes’.
More than four people died from sepsis after using the eye drops, 14 people experienced vision loss and more than 80 were infected.
The eyedrops were sold by EzriCare Artificial Tears and as own brand products sold at CVS, Walmart, Rite Aid and Target among others.
The contamination was linked back to a manufacturing issue at the Global Pharma Healthcare plant in India where they were produced. It had inadequate microbial testing and did not include proper preservatives in the drugs.
