Nearly 60,000 bottles of a commonly prescribed blood pressure medication have been recalled nationwide after a serious packaging error was discovered, according to a recent announcement by the U.S. Food and Drug Administration (FDA).
On July 17, the FDA confirmed an “ongoing” Class II recall of Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, manufactured by Lupin Limited in India and distributed by Lupin Pharmaceuticals Inc., based in Baltimore, MD. The medication was distributed across the U.S. in 100-count bottles under lot number QA01081, with an expiration date of April 2027.
The recall was initiated after a consumer complaint revealed a foreign tablet—identified as a 300mg/100mg combination of Atazanavir and Ritonavir, which are antiretroviral drugs used to treat HIV-1 infections—had been found in a sealed bottle labeled for the blood pressure medication.
The mix-up is classified as a Class II recall, meaning the affected product may cause temporary or medically reversible health problems. Though no injuries or adverse events have been reported to date, the FDA warns that patients with high blood pressure could potentially miss needed doses or unknowingly ingest incorrect medication.
Lisinopril, an ACE inhibitor, and Hydrochlorothiazide, a diuretic, are often prescribed together to manage hypertension by relaxing blood vessels and reducing excess fluid in the body—essential for millions of Americans managing heart, kidney, and vascular conditions.
What Consumers Should Do:
- Check the bottle for the lot number QA01081.
- Stop use immediately if your product matches.
- Return the medication to the place of purchase or follow the recall instructions from Lupin Pharmaceuticals.
- Report any adverse effects to your healthcare provider and the FDA’s MedWatch program.
This incident underscores the vital importance of quality control in pharmaceutical manufacturing and the necessity for consumer vigilance in ensuring medication safety.