FDA Drug recall D-0484-2026
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Pisca…
- FDA Drug
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Pisca… by Hetero Labs Unit V, citing discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots.".
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0484-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-26 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hetero Labs Unit V |
| Distribution | US |
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
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Identifiers
| ndc | 31722-712-90 |
|---|---|
| ndc | 31722-712-32 |
| ndc | 31722-712-31 |
| ndc | 31722-713-90 |
| ndc | 31722-713-32 |
| ndc | 31722-713-31 |
| ndc | 31722-713-10 |
| code_info | Batch # FD253967, Exp Date: 06/26/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0484-2026%22
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