Check your medicine cabinet. A popular blood pressure medication, distributed by a New Jersey-based pharmaceutical company, has been recalled nationwide.
On April 23, Unique Pharmaceutical Laboratories, a division of JB Chemicals and Pharmaceuticals Ltd based in Mumbai, India, recalled 675 bottles of Enalapril Maleate Tablets USP in 20-milligram, 1,000-count bottles.
The product was distributed by Rising Pharma Holdings, Inc., based in East Brunswick, New Jersey. The FDA published notice of the recall on May 5.
Why It Was Recalled
The recall was triggered by a failed impurities and degradation test—specifically, an out-of-specification result in an organic impurities test.
While the specific compound that triggered the finding has not been publicly identified, the recall comes amid a broader regulatory environment in which multiple blood pressure medications have been flagged in recent years for the development of nitrosamines. The chemical compounds, which are linked to cancer, can form inadvertently over time or due to environmental conditions.
The FDA has not yet confirmed that nitrosamines are the issue identified with Enalapril Maleate.
The recall has been designated Class II by the FDA, defined as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.” The recall is voluntary and firm-initiated.
Affected bottles can be identified by lot number GEH25023, with an expiration date of 6/30/2027, and a National Drug Code (NDC) of 64980-688-10. The medication was distributed nationwide.
Enalapril Maleate is an ACE inhibitor used to treat hypertension and heart failure. If you are currently taking this medication, it is not advisable to stop without first speaking to your doctor—abruptly discontinuing heart-related medications can carry its own set of risks.
If you believe you have an affected bottle, you should contact your healthcare provider to determine next steps.