Pantoprazole Sodium Delayed Release Tablets — Class II drug recall D-0145-2020
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2019-10-23, distributed in MS, OH, PR, RI, TN. CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
| Recall number | D-0145-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2019-09-04 |
| Classified | 2019-10-17 |
| Reported by FDA | 2019-10-23 |
| Terminated | 2020-02-12 |
| Distributed | MS, OH, PR, RI, TN |
| Quantity | 63,216 bottles |
| Reason classes | cgmp |
| NDC | 59746-0284-90 |
| Lot numbers | PA218P008, PA218P009 |
| Expiration dates | 2021-04 |
Product
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
Reason for recall
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
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-0145-2020. 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.