Lisinopril tablets — Class II drug recall D-0478-2017
Terminated recall by Accord Healthcare, Inc., reported 2017-02-22, distributed nationwide. Failed tablet/capsule specification: missing break line on the 5mg tablet.
| Recall number | D-0478-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2016-12-20 |
| Classified | 2017-02-16 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2017-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 12,896 bottles |
| Reason classes | device malfunction |
| NDC | 16729-0376-17 |
| Lot numbers | 2/18, 4/18, 5/18, T04483, T04484, T06028, T08423 |
Product
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
Reason for recall
Failed tablet/capsule specification: missing break line on the 5mg tablet.
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-0478-2017. 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.