More than 600,000 bottles of blood pressure medicine sold in the US have been recalled over concerns they could be contaminated.
Ramipril is prescribed to more than 2.4 million Americans annually and is used to lower blood pressure by widening blood vessels.
But the FDA issued a recall because the drugs were made with ingredients from a supplier in India whose factory had not been inspected or approved by the agency.
This raises concerns that the capsules could pose a risk of contamination.
But the overall risk to the public is low, the agency said, and no side effects have been reported so far from using the drugs.
The recall affects capsules of the drug, made by Indian company Lupine Pharmaceuticals and sold in strengths of 2.5 milligrams (mg), 5 mg and 10 mg.
They come in bottles of 90, 100 or 500 capsules and have an expiration date until July 2026.
The capsules were manufactured in Goa, India, and the recall was launched on October 23 for the 10 mg and 5 mg strengths. This was expanded on November 19 with 2.5 mg doses.
Above is a 5 mg strength bottle of ramipril containing 500 capsules, sold by Lupine Pharmaceuticals. Versions of this drug are being recalled
An FDA inspection found that an active pharmaceutical ingredient (API), the key ingredient in a drug that causes it to work, was made by a separate manufacturer that was not approved by the agency.
The recall is categorized as Class II, which is issued when a product has a low probability of causing serious injury or death.
A Class I action exists when there is a reasonable likelihood of injury.
A total of 350,000 bottles of the 10 mg capsules have been recalled, as well as 146,000 bottles of the 5 mg capsules and 110,000 bottles of the 2.5 mg.
The bottles were sold in at least 30 suppliers across the country, which have not been named.
Customers are advised to throw away the bottles or return them to the sellers for a full refund.
They are also advised to contact their doctor to ask about next steps and new prescriptions.
A full list of the recalled bottles was revealed on the FDA website.
Lupine Pharmaceuticals did not respond to a DailyMail.com request for comment.
It comes about two weeks after Indian drugmaker Dr. Reddy’s Laboratories has recalled 331,500 bottles of medical tablets due to the presence of carcinogenic material.
The cinacalcet tablets were used to treat hyperparathyroidism, a common condition diagnosed in 100,000 people every year in which hormone problems cause high levels of calcium in the blood.
But they were recalled after FDA testing showed they were contaminated with high levels of a nitrosamine-related impurity, which has been linked to cancer.
The company did not disclose where the tablets were manufactured and it was a Class II recall.
Last year, over-the-counter eye drops from 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 of sepsis after using the eye drops, 14 people suffered from vision loss and more than 80 became infected.
The eye drops were sold by EzriCare Artificial Tears and sold as private label products at CVS, Walmart, Rite Aid and Target, among others.
The contamination was related to a production problem at the Global Pharma Healthcare plant in India where they were produced. Insufficient microbial testing had been carried out and proper preservatives had not been included in the medicines.