High blood pressure is a serious concern, as health experts estimate it was either a “primary or contributing cause” for more than 664,000 deaths in 2023. But, as the Cleveland Clinic warns, hypertension—another term for high blood pressure—can be known as a “silent killer,” as many people don’t observe their signs or symptoms directly related to it. There are cases when, if left untreated, high blood pressure may also result in health effects ranging from sexual dysfunction and kidney disease to heart failure or stroke, according to the American Heart Association.
But one trusted drug combo prescribed to address this concern—from a manufacturer named in another recent blood pressure medication recall—is now facing a nationwide recall.
Tuesday, the U.S. Food and Drug Administration (FDA) announced a “ongoing” recall of 7,668 bottles of Amlodipine and Benazepril HCL Capsules. The medication, whose formulation is sometimes known by the brand name Lotrel, was reportedly distributed throughout the U.S.
The FDA indicates an apparent labeling issue was reported, with the official recall reason listed as “Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027.” [sic]
The listed recalling firm, Lupin Pharmaceuticals Inc. in Naples, FL, was also named in a separate blood pressure medication recall we reported on last week.
Similar to last week’s recall, the affected medication once again is a combination of two drugs focused on lowering blood pressure: amlodipine as a calcium channel blocker and benazepril as angiotensin-enzyme (ACE) inhibitor, according to the Mayo Clinic. Both drugs work to relax blood vessels—amlodipine by affecting “the movement of calcium into the cells of the heart and blood vessels;” benazepril by “blocking a substance in the body that causes the blood vessels to tighten”—in turn lowering blood pressure, notes Mayo.
Taking an expired medication can be dangerous, according to FDA guidelines, as changes in chemical compositions or decreases in drug strength are possible. “Once the expiration date has passed there is no guarantee that the medicine will be safe and effective,” says the agency, further stating: “If your medicine has expired, do not use it.”
Product details include:
- Amlodipine and Benazepril HCL Capsules USP 2.5 mg/10 mg (mg stands for milligram)
- 100 Capsules bottle
- Rx Only
- Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States
- Manufactured by: Lupin Limited, Goa 103 722, India
- NDC (National Drug Code): 68180-755-01
- Lot Code: GB01616
- Expiration: 2/28/2027
The FDA designated the recall as a Class II event on Monday, though from the report it appears to have been first initiated on July 2. The Class II label indicates the agency has determined it’s “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.”
For daily wellness updates, subscribe to The Healthy by Reader’s Digest newsletter and follow The Healthy on Facebook and Instagram. Keep reading: