Lisinopril Tablets — Class III drug recall D-498-2013
Terminated recall by Aurobindo Pharma USA Inc, reported 2013-06-05, distributed nationwide. Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
| Recall number | D-498-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc, Plainsboro, NJ, United States |
| Recall initiated | 2013-04-09 |
| Classified | 2013-05-30 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,776 bottles |
| Reason classes | labeling, potency |
| NDC | 65862-0037, 65862-0037-00, 65862-0037-01, 65862-0037-05, 65862-0037-30, 65862-0037-99, 65862-0038, 65862-0038-00, 65862-0038-01, 65862-0038-05, 65862-0038-30, 65862-0038-99, 65862-0039, 65862-0039-00, 65862-0039-01, 65862-0039-05, 65862-0039-30, 65862-0039-99, 65862-0040, 65862-0040-00, 65862-0040-01, 65862-0040-05, 65862-0040-30, 65862-0040-99, 65862-0041 and 11 more |
| Lot numbers | 12/13, KP3012001-A, KP3012002-A |
Product
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
Reason for recall
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
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-498-2013. 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.