Enalapril Maleate Tablets Recalled Due to Failed Impurities/Degradation Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for enalapril maleate tablets, USP, 20 mg. The affected batch has been identified as Lot GEH25023 (expiration date June 30, 2027), which includes 675 bottles.
• The recall was initiated by JB Chemicals and Pharmaceuticals Ltd due to failed impurities/degradation specifications, a quality issue that may cause temporary or medically reversible adverse health consequences.
• Enalapril maleate tablets are used to treat high blood pressure and congestive heart failure.

The FDA has issued a Class II recall for enalapril maleate tablets, USP, 20 mg. This medication is manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd, in Mumbai, India. The drug is distributed nationwide by Rising Pharma Holdings, Inc in East Brunswick, New Jersey. The recall was initiated on April 23, 2026, and received a Class II classification on May 5, 2026.

The recall was initiated due to failed impurities/degradation specifications during an Organic Impurities Test, particularly for Lot GEH25023, which expires on June 30, 2027. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, and the probability of serious adverse health consequences is low. J.B. Chemicals & Pharmaceuticals sent out a public notice via letter; no public press release has been issued for this recall.

Enalapril maleate tablets are a prescription medication used to treat hypertension and congestive heart failure. Pharmacists should identify and quarantine Lot GEH25023, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. May 13, 2026. Accessed May 13, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219842