Rabeprazole Sodium Delayed Release Tablets — Class II drug recall D-0693-2017
Terminated recall by Amneal Pharmaceuticals LLC, reported 2017-05-10, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0693-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals LLC, Glasgow, KY, United States |
| Recall initiated | 2016-12-12 |
| Classified | 2017-05-02 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2019-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 105,215 bottles |
| Reason classes | specification failure |
| NDC | 65162-0724-03, 65162-0724-09 |
| Expiration dates | 2017-09, 2018-05 |
Product
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
Reason for recall
Failed Dissolution Specifications
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-0693-2017. 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.