Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg*… — Class II drug recall D-0068-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-11-30, distributed nationwide. Discoloration
| Recall number | D-0068-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-07-25 |
| Classified | 2022-11-22 |
| Reported by FDA | 2022-11-30 |
| Terminated | 2023-09-13 |
| Distributed | Nationwide (US) |
| NDC | 62756-0071, 62756-0071-60, 62756-0071-64 |
| Lot numbers | MHC1317A |
| Expiration dates | 2023-07 |
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 for recall
Discoloration
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-0068-2023. 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.