Pantaprazole Sodium Delayed Release Tablets — Class II drug recall D-1042-2014
Terminated recall by Wockhardt Usa Inc., reported 2014-02-05, distributed nationwide. Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specification
| Recall number | D-1042-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wockhardt Usa Inc., Parsippany, NJ, United States |
| Recall initiated | 2013-11-27 |
| Classified | 2014-01-29 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2015-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,129 bottles |
| Reason classes | specification failure |
| NDC | 64679-0434-02 |
| Lot numbers | 06/14, DM12286 |
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 for recall
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit 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-1042-2014. 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.