Enalapril Maleate Tablets recall: Impurity Out of Spec
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.
Why was Enalapril Maleate Tablets recalled?
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: GEH25023, Expires: 6/30/2027
- 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.
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
- Quantity
- 675 bottles
- Distribution
- Nationwide in the USA
- Recall date
- May 13, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)