More than **“600,000 bottles”** of the blood pressure medication ramipril have been recalled in the United States after the FDA found the drug may be contaminated. The issue arose when ingredients were traced to **“an uninspected and unapproved manufacturing facility in India,”** prompting regulatory action.
Ramipril is commonly prescribed to treat high blood pressure and is used by **“more than 2.4 million Americans annually.”** It works by relaxing blood vessels. Although **“no adverse events have been reported so far,”** the FDA warned the capsules could still pose a contamination risk. Officials emphasized that the overall risk to public health is considered low.
The recall affects ramipril made by Lupin Pharmaceuticals. Impacted bottles include the 2.5 mg, 5 mg, and 10 mg strengths, packaged in counts of 90, 100, or 500 capsules, with expiration dates through July 2026. The recall originally applied to the 5 mg and 10 mg doses, but on **“November 19, the 2.5mg dose was added.”**
According to the FDA, the active ingredient came from a facility in Goa, India that lacked approval or inspection. This led to a **“Class II recall,”** defined as a situation with a **“low probability of severe injury or death”** but possible adverse effects.
Consumers are advised to dispose of or return affected bottles for a refund and consult their doctor before stopping or changing medication. The FDA notes this recall adds to broader concerns, following other incidents involving Indian-made drugs and contamination issues.
