FDA DrugsClass II
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured...
Published: May 13, 2026Recall ID: D-0520-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Mumbai |
| Openfda › Unii | 9O25354EPJ |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 858804 |
| Openfda › Rxcui › 2 | 858810 |
| Openfda › Rxcui › 3 | 858813 |
| Openfda › Rxcui › 4 | 858817 |
| Openfda › Spl id | 6f4c73c0-8b68-485d-87f6-cd77746aada8 |
| Openfda › Brand name | ENALAPRIL MALEATE |
| Openfda › Spl set id | 71e9fff3-7283-437e-b107-72fc16f09989 |
| Openfda › Package ndc › 1 | 64980-685-01 |
| Openfda › Package ndc › 2 | 64980-685-10 |
| Openfda › Package ndc › 3 | 64980-686-01 |
| Openfda › Package ndc › 4 | 64980-686-10 |
| Openfda › Package ndc › 5 | 64980-687-01 |
| Openfda › Package ndc › 6 | 64980-687-10 |
| Openfda › Package ndc › 7 | 64980-688-01 |
| Openfda › Package ndc › 8 | 64980-688-10 |
| Openfda › Product ndc › 1 | 64980-685 |
| Openfda › Product ndc › 2 | 64980-686 |
| Openfda › Product ndc › 3 | 64980-687 |
| Openfda › Product ndc › 4 | 64980-688 |
| Openfda › Generic name | ENALAPRIL MALEATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | ENALAPRIL MALEATE |
| Openfda › Manufacturer name | Rising Pharma Holdings, Inc. |
| Openfda › Application number | ANDA218531 |
| Openfda › Is original packager | true |
| Event id | 98794 |
| Address 1 | Neelam Centre A Wing A B Wing |
| Address 2 | 4th Floor; Hind Cycle Road |
| Code info | Lot #: GEH25023, Expires: 6/30/2027 |
| Postal code | N/A |
| Report date | 20260513 |
| Product type | Drugs |
| Product quantity | 675 bottles |
| Reason for recall | Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260423 |
| Initial firm notification | Letter |
| Center classification date | 20260505 |
Overview
- Recalling FirmJB Chemicals and Pharmaceuticals Ltd
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA