Enalapril Maleate Tablets — Class III drug recall D-0979-2018
Terminated recall by MAJOR PHARMACEUTICALS, reported 2018-08-01, distributed nationwide. Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the m
| Recall number | D-0979-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MAJOR PHARMACEUTICALS, Livonia, MI, United States |
| Recall initiated | 2018-06-26 |
| Classified | 2018-07-24 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2019-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 3,397 cartons |
| Reason classes | specification failure |
| NDC | 00904-5609-61 |
| Lot numbers | 07/19, 08/18, 08/19, 09/18, 10/19, DR10447A, DS10201A, DS10201B, DS10201C, DS10319A, T-01083 |
Product
Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5609-61.
Reason for recall
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
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-0979-2018. 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.