Pantoprazole Sodium Delayed-Release Tablets USP — Class II drug recall D-1499-2016
Terminated recall by Aurobindo Pharma USA Inc, reported 2016-09-21, distributed in CA. Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tab
| Recall number | D-1499-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc, Plainsboro, NJ, United States |
| Recall initiated | 2016-08-03 |
| Classified | 2016-09-14 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2018-06-08 |
| Distributed | CA |
| Quantity | 23,016 bottles |
| NDC | 65862-0560-90 |
Product
Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90
Reason for recall
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
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-1499-2016. 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.