FDA Drug recall D-0068-2023
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pant…
- FDA Drug
- Class II
- terminated
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class II recall of Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pant… by Sun Pharmaceutical Industries, citing discoloration.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0068-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-07-25 |
| Published | 2022-11-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60
Reason
Discoloration
Identifiers
| ndc | 62756-071-60 |
|---|---|
| ndc | 62756-071-64 |
| code_info | Lot #: MHC1317A, Exp 07/2023 |
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-0068-2023%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.