According to the Centers for Disease Control and Prevention (CDC), almost half of the adult population in the U.S.—or 119.9 million people—are currently living with high blood pressure, also known as hypertension. Many of these people manage the chronic condition with the help of lifestyle changes and medication. The latter includes angiotensin-converting enzyme (ACE) inhibitors, calcium blockers, diuretics, and others.
Last month, on October 23, the U.S. Food and Drug Administration (FDA) recalled 112,770 bottles of one popularly prescribed ACE inhibitor, Ramipril, produced by Lupin Pharmaceuticals Inc., a Baltimore, MD-based company.
On November 19, the health authority issued a risk classification update for the ongoing recall, assigning it a Class II designation. This is the mid-tier risk level on a three-tier scale, indicating “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The update pertains to three types of Ramipril 2.5 mg capsules:
- 90 count (NDC 68180-589-09, Lots G326781, exp. date September 30, 2025, GA04468, exp. date May 31, 2025 )
- 100 count (NDC 68180-589-01, Lots G326763, exp. date September 30, 2025, GA03041, exp. date March 31, 2026, GA03725, exp. date April 30, 2026, GA04402, exp. date May 31, 2026)
- 500 count (NDC 68180-589-02, Lots G326782, exp. date September 30, 2025, GA04462, exp. date May 31, 2026)
However, a letter written by The California State Board of Pharmacy indicates that an additional 8 lots of Ramipril Capsules USP 5 mg and 13 lots of Ramipril Capsules USP 10 mg were also recalled to the retail level.
According to the FDA’s notice, the products were found to have used manufacturing techniques that deviated from Current Good Manufacturing Practice (cGMP).
The health authority notes that an “active pharmaceutical ingredient was sourced from an unapproved vendor.” It was not immediately clear from the recall notice which ingredient was considered compromised, but the California Board calls it a “key starting material.”
The products were produced in Goa, India, and were distributed to 30 wholesalers and distributors “who may have further distributed the product nationwide” within the U.S., the report says.
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Besides being used to treat high blood pressure, Ramipril is also sometimes used to treat heart failure. According to the Cleveland Clinic, it can help heal heart damage after a heart attack. The drug works by relaxing and widening your blood vessels, making it easier for your heart to pump blood throughout the body.
The California Board says that it “strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required.”
Consumers who may have the drugs in their possession should not take them. Instead, discard them or return them to your place of purchase.
