FDA Drug recall D-0875-2023
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
- FDA Drug
- Class III
- ongoing
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class III recall of Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13 by Avkare, citing failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0875-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-06-13 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Reason
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Identifiers
| ndc | 50268-772-11 |
|---|---|
| ndc | 50268-772-13 |
| code_info | Lot: 44286 Exp. 02/2025 |
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-0875-2023%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.