FDA Drug recall D-0145-2020
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roor…
- FDA Drug
- Class II
- terminated
- Published 2019-10-23
On 2019-10-23 the FDA classified a Class II recall of Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roor… by Jubilant Cadista Pharmaceuticals, citing CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0145-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-04 |
| Published | 2019-10-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | MS, OH, PR, RI, TN |
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
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Identifiers
| code_info | Lot # PA218P008, PA218P009, Exp 04/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0145-2020%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.