More than 600,000 bottles of the blood pressure medication ramipril have been recalled across the United States due to concerns over potential contamination.
The FDA issued the recall after discovering that the drug contained ingredients from an uninspected and unapproved manufacturing facility in India.
What is Ramipril?
Ramipril is a widely prescribed medication, used by more than 2.4 million Americans annually, to manage high blood pressure by relaxing blood vessels. While no adverse events have been reported so far, the FDA cautions that the capsules could pose a contamination risk, though the overall threat to public health is considered low.
Details of the Recall
The recall involves bottles of ramipril produced by Lupin Pharmaceuticals, an Indian company. The affected capsules are available in three strengths:
- 2.5 mg
- 5 mg
- 10 mg
The bottles contain 90, 100, or 500 capsules and have expiration dates extending to July 2026. Initially, the recall targeted the 5mg and 10mg strengths, but on November 19, the 2.5mg dose was added.
FDA Findings
The FDA revealed that the active pharmaceutical ingredient (API) in the capsules was sourced from a manufacturer in Goa, India, which had not undergone proper inspection or approval. This triggered a Class II recall, which indicates a low probability of severe injury or death but acknowledges the potential for adverse effects.
