Pantoprazole Sodium Delayed Release Tablets USP 40mg — Class II drug recall D-0530-2023
Ongoing recall by Hetero USA Inc, reported 2023-04-19, distributed nationwide. CGMP Deviations: Discoloration
| Recall number | D-0530-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Recalling firm | Hetero USA Inc, Piscataway, NJ, United States |
| Recall initiated | 2023-03-14 |
| Classified | 2023-04-11 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 2,352 bottles |
| Reason classes | cgmp |
| NDC | 31722-0712, 31722-0712-31, 31722-0712-32, 31722-0712-90, 31722-0713, 31722-0713-10, 31722-0713-31, 31722-0713-32, 31722-0713-90 |
| Lot numbers | PAN22542 |
| Expiration dates | 2024-09 |
Product
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
Reason for recall
CGMP Deviations: 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-0530-2023. 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.