Pantoprazole Sodium — Class II drug recall D-0484-2026
Ongoing recall by Hetero Labs Limited (Unit V), reported 2026-04-29, distributed nationwide. Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have
| Recall number | D-0484-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero Labs Limited (Unit V), Mahabubnagar, N/A, India |
| Recall initiated | 2026-03-26 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| 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 | FD253967 |
| Expiration dates | 2027-06-26 |
Product
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
Reason for recall
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
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-0484-2026. 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.