FDA Drug recall D-0520-2026
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Che…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Che… by Jb Chemicals And Pharmaceuticals, citing failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0520-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-23 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jb Chemicals And Pharmaceuticals |
| Distribution | US |
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
Identifiers
| ndc | 64980-685-01 |
|---|---|
| ndc | 64980-685-10 |
| ndc | 64980-686-01 |
| ndc | 64980-686-10 |
| ndc | 64980-687-01 |
| ndc | 64980-687-10 |
| ndc | 64980-688-01 |
| ndc | 64980-688-10 |
| code_info | Lot #: GEH25023, Expires: 6/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0520-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.