FDA Drug recall D-0530-2023
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscatawa…
- FDA Drug
- Class II
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class II recall of Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscatawa… by Hetero Usa, citing CGMP Deviations: Discoloration.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0530-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-14 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hetero Usa |
| Distribution | US |
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
CGMP Deviations: Discoloration
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 | Lot #: PAN22542, Exp. Date: 9/2024 |
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-0530-2023%22
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