Enalapril Maleate Tablets — Class II drug recall D-0520-2026
Ongoing recall by JB Chemicals and Pharmaceuticals Ltd, reported 2026-05-13, distributed nationwide. Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
| Recall number | D-0520-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | JB Chemicals and Pharmaceuticals Ltd, Mumbai, India |
| Recall initiated | 2026-04-23 |
| Classified | 2026-05-05 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 675 bottles |
| Reason classes | specification failure |
| NDC | 64980-0685, 64980-0685-01, 64980-0685-10, 64980-0686, 64980-0686-01, 64980-0686-10, 64980-0687, 64980-0687-01, 64980-0687-10, 64980-0688, 64980-0688-01, 64980-0688-10 |
| Lot numbers | GEH25023 |
| Expiration dates | 2027-06-30 |
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 for recall
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0520-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.