National estimates suggest around 34 million American adults “may need a prescription or to fill their prescription and start taking it” due to high blood pressure. The American Heart Association notes several classes of available drugs aimed at helping this very health issue—but a recent notice from a prominent U.S. agency names a combination of two common medication types at the center of a nationwide recall effort.

Last Friday, the U.S. Food and Drug Administration (FDA) announced an “ongoing” recall of 58,968 bottles of Lisinopril and Hydrochlorothiazide tablets. The listed recalling firm is Naples, FL-based Lupin Pharmaceuticals Inc. The drug was reportedly distributed across the U.S.

The combination of Lisinopril and Hydrochlorothiazide—sometimes associated with the brand names of Prinzide or Zestoretic—works to treat high blood pressure. As an ACE inhibitor, Lisinopril blocks “a substance in the body that causes blood vessels to tighten,” while Hydrochlorothiazide works as a diuretic (also known as a water pill), lowering blood pressure by helping to regulate fluid, thereby taking stress off the heart, kidneys, and blood vessels, according to the Mayo Clinic.

The FDA names a “Product Mix Up” as the recall reason, further expanding: “This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.”

Atazanavir Sulfate and Ritonavir tablets are prescribed for the treatment of HIV-1 infections, according to FDA documentation.

Product details include:

  • Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg (abbreviated for “milligram”)
  • 100-count bottles
  • Rx only
  • Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202
  • Manufactured by: Lupin Limited Nagpur-441 108, INDIA
  • NDC (National Drug Code): 68180-519-01
  • Lot #: QA01081
  • Expiration Date: April 2027

The recall, first initiated on June 20, was designated as a Class II event on Thursday, July 17. Class II recalls involve products that may cause temporary or medically reversible adverse health effects.

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