FDA Drug recall D-0166-2024
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540
- FDA Drug
- Class II
- terminated
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540 by Cardinal Healthcare, citing CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0166-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Healthcare |
| Distribution | US |
Product
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Identifiers
| ndc | 0781-2020-31 |
|---|---|
| ndc | 0781-2020-76 |
| ndc | 0781-2020-01 |
| ndc | 0781-2020-05 |
| ndc | 0781-2613-31 |
| ndc | 0781-2613-76 |
| ndc | 0781-2613-01 |
| ndc | 0781-2613-05 |
| ndc | 0781-5060-20 |
| ndc | 0781-5060-01 |
| ndc | 0781-5061-20 |
| ndc | 0781-5061-01 |
| ndc | 0781-6039-58 |
| ndc | 0781-6039-46 |
| ndc | 0781-6039-55 |
| ndc | 0781-6156-52 |
| ndc | 0781-6156-57 |
| ndc | 0781-6156-46 |
| ndc | 0781-6041-58 |
| ndc | 0781-6041-46 |
| ndc | 0781-6041-55 |
| ndc | 0781-6157-52 |
| ndc | 0781-6157-57 |
| ndc | 0781-6157-46 |
| code_info | Batch LJ9004 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0166-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.