Pantoprazole Sodium Delayed Release Tablets USP — Class II drug recall D-296-2013
Terminated recall by Jubilant Cadista Pharmaceuticals Inc., reported 2013-05-08, distributed nationwide. cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
| Recall number | D-296-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD, United States |
| Recall initiated | 2013-02-11 |
| Classified | 2013-04-26 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2013-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 12,770 bottles |
| Reason classes | cgmp |
| NDC | 59746-0284-90 |
| Lot numbers | PA22028, PA22029 |
| Expiration dates | 2014-05 |
Product
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Reason for recall
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
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-296-2013. 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.