Enalapril Maleate Tablets recall (JB Chemicals and Pharmaceuticals Ltd)
DrugClass IIOngoing
Summary: JB Chemicals and Pharmaceuticals Ltd is recalling 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.
What is being recalled
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
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot #: GEH25023, Expires: 6/30/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0520-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 23, 2026 |
| Reported | May 13, 2026 |
| Company | JB Chemicals and Pharmaceuticals Ltd |
| Company location | Mumbai, India |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 675 bottles |
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