FDA Drug recall D-0868-2017
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for…
- FDA Drug
- Class III
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class III recall of Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for… by Sandoz, citing subpotent Drug; Clavulanic Acid.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0868-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-04-26 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | NY, OH |
Product
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20
Reason
Subpotent Drug; Clavulanic Acid
Identifiers
| ndc | 0781-1874-31 |
|---|---|
| ndc | 0781-1831-20 |
| ndc | 0781-1831-13 |
| ndc | 0781-1831-01 |
| ndc | 0781-1852-20 |
| ndc | 0781-1852-13 |
| ndc | 0781-1852-01 |
| ndc | 0781-6102-46 |
| ndc | 0781-6102-57 |
| ndc | 0781-6102-52 |
| ndc | 0781-6104-46 |
| ndc | 0781-6104-57 |
| ndc | 0781-6104-52 |
| code_info | Lot FP8735, 8/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0868-2017%22
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