FDA Drug recall D-1058-2020
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 In…
- FDA Drug
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 In… by Jubilant Cadista Pharmaceuticals, citing CGMP Deviations: Presence of dark brown discoloration on edges of tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1058-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-11 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | US |
Product
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
Reason
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Identifiers
| code_info | Lot # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021 |
|---|
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-1058-2020%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.