60,000 Bottles of Blood Pressure Medication Recalled Due to Safety Concerns
The U.S. Food and Drug Administration (FDA) has announced a major recall affecting nearly 60,000 bottles of a common blood pressure medication. The recall involves certain batches of Lisinopril and Hydrochlorothiazide tablets manufactured by Lupin Pharmaceuticals.
Why Was This Blood Pressure Medication Recalled?
The voluntary recall was initiated after the discovery of potential contamination risk. Testing revealed traces of a nitrosamine impurity called NMBA (N-Nitroso-N-methyl-4-aminobutyric acid) above acceptable safety levels.
While NMBA is classified as a possible human carcinogen, the FDA emphasizes that the immediate health risk to patients is low. However, prolonged exposure above safe levels may increase cancer risk.
Affected Products and Lot Numbers
The recall includes the following medications:
- Lisinopril and Hydrochlorothiazide Tablets - 20 mg/12.5 mg (NDC 68180-918-09)
- Lot numbers: L200183, L200184, L200185, L200208, L200209, and L200210
- Expiration dates: Between October 2024 and November 2024
What Should Patients Do?
If you take this medication, follow these steps:
- Check your prescription bottle for the listed lot numbers
- Do not stop taking your medication without consulting your doctor
- Contact your pharmacist for replacement medication if affected
- Return any unused tablets from recalled lots to your pharmacy
Understanding the Health Risks
While the contamination poses minimal immediate danger, the FDA recommends:
- There's no need for emergency medical attention
- Short-term use (even at higher NMBA levels) presents low risk
- Chronic exposure is the primary concern
Additional Resources for Concerned Patients
For more information:
- Contact Lupin Pharmaceuticals at 1-800-399-2561 (Monday-Friday, 8 AM-5 PM EST)
- Visit the FDA's recall website for updates
- Report any adverse reactions to the FDA MedWatch program
This recall follows similar actions in recent years as pharmaceutical companies increase testing for nitrosamine impurities in medications.
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