The FDA recalls blood pressure medicine expanded nationwide Thursday after the U.S. Food and Drug Administration pulled more than 11,000 bottles of bisoprolol-HCTZ tablets due to cross contamination found during routine testing. The FDA recalls blood pressure medicine prompted a precautionary withdrawal of specific lots after safety checks detected traces of a cholesterol medication.
FDA Warns Consumers After Contaminant Found in Routine Tests
The FDA said 11,136 bottles of bisoprolol fumarate and hydrochlorothiazide tablets were removed from distribution after testing identified traces of ezetimibe, a drug used to treat high cholesterol. The detection occurred during standard quality checks, which monitor the safety of medications circulating in pharmacies throughout the country.
The recall applies to the 2.5-milligram and 6.25-milligram strengths of the tablets. These products were sold in 30-count, 100-count and 500-count bottles and were manufactured by Glenmark Pharmaceuticals Limited. The affected bottles include lot codes 17232401 and 17240974, with expiration dates of November 2025 and May 2026.
The FDA recalls blood pressure medicine was classified the action as a Class III recall. According to the FDA’s recall definitions, Class III recalls are issued when a product is not likely to cause adverse health consequences. This classification indicates the contamination level did not present an immediate medical risk but still required removal to maintain manufacturing and safety standards.
The FDA said no illnesses or reactions have been reported in connection with the recall.
Recall Covers Multiple Strengths and Bottle Sizes Sold Nationwide
The recalled medication is commonly prescribed to treat high blood pressure, often for long-term use. Because the tablets were distributed in several bottle sizes, the FDA urged consumers to review their prescription labels closely. The agency noted that lot numbers and expiration dates provide the quickest way to determine whether a bottle is part of the recall.
The recall affects products distributed throughout the United States, meaning consumers in any state may have received an impacted bottle. Pharmacies and distributors were notified to stop dispensing the affected lots and remove any remaining bottles from their inventories.
Although the FDA recalls blood pressure medicine is considered low risk, the FDA stressed the importance of patients checking their medication even if they have not experienced any problems. Cross contamination, even at low levels, can alter the intended formulation of a prescription drug, and accurate dosing is essential for conditions such as hypertension.
Patients Encouraged to Review Prescriptions and Contact Pharmacists
Patients who discover that their medication matches one of the recalled lots are advised to contact their pharmacist or healthcare provider. Pharmacists can verify whether a bottle is included in the recall and arrange for a replacement if needed. The FDA noted that individuals should not dispose of the medication on their own without receiving proper instructions from a pharmacist or prescriber.
Those who take the medication regularly are encouraged to review their supply promptly to avoid disruptions in their treatment plan. Although no harmful reactions have been reported, the FDA recommended that anyone with concerns about the recall or their medication speak with a healthcare professional.
Consumers may contact the FDA hotline at 1-888-INFO-FDA (1-888-463-6332) for more details. The agency continues to monitor the FDA recalls blood pressure medicine and will share updates as needed.