Enalapril Maleate Tablets USP — Class III drug recall D-0915-2018
Terminated recall by AMERICAN HEALTH PACKAGING, reported 2018-07-18. Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
| Recall number | D-0915-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Recalling firm | AMERICAN HEALTH PACKAGING, Columbus, OH, United States |
| Recall initiated | 2018-06-25 |
| Classified | 2018-07-09 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-04-29 |
| Reason classes | specification failure |
| NDC | 68084-0390-01, 68084-0390-11 |
| Lot numbers | 166023, 168467 |
| Expiration dates | 2018-11-30, 2019-02-28 |
Product
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
Reason for recall
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
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-0915-2018. 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.