FDA Drug recall D-1042-2014
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only
- FDA Drug
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only by Wockhardt Usa, citing failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1042-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-27 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Wockhardt Usa |
| Distribution | US |
Product
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
Reason
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Identifiers
| code_info | Lot: #: DM12286, Expiry: 06/14. |
|---|
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-1042-2014%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.