FDA Drug recall D-1499-2016
Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Rout…
- FDA Drug
- Class II
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class II recall of Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Rout… by Aurobindo Pharma Usa, citing 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 Pa….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1499-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-03 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | CA |
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
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.
Identifiers
| code_info | PSSB16011-A, Exp 01/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1499-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.