Jb Chemicals And Pharmaceuticals Ltd: Enalapril Maleate Tablets, Usp, 20 Mg, 1,000-count Bottle
Recall Summary Enalapril Maleate Tablets 20 mg (a blood pressure medication) in 1,000-count bottles manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings are being recalled nationwide because they failed quality testing for organic impurities and degradation. The affected product has NDC number 64980-688-10 and was distributed across all U.S. states and Washington, D.C. This is classified as a Class II recall, meaning the product could cause temporary or medically reversible effects.
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
- Product
- Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
- Reason
- Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-23
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/a8fb1f65-a4a6-4956-bc41-0687c25b3e23