FDA Drug recall D-0011-2019
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 2476…
- FDA Drug
- Class II
- terminated
- Published 2018-10-17
On 2018-10-17 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 - 2476… by Jubilant Cadista Pharmaceuticals, citing discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0011-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-02 |
| Published | 2018-10-17 |
| 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; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
Reason
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Identifiers
| code_info | Lot #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071…Lot #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21. |
|---|
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-0011-2019%22
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