Tranexamic Acid USP Tablets — Class III drug recall D-0875-2023
Ongoing recall by AVKARE LLC, reported 2023-06-21, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
| Recall number | D-0875-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE LLC, Pulaski, TN, United States |
| Recall initiated | 2023-06-13 |
| Classified | 2023-06-15 |
| Reported by FDA | 2023-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 592 cartons |
| Reason classes | specification failure |
| NDC | 50268-0772, 50268-0772-11, 50268-0772-13 |
| Lot numbers | 44286 |
| Expiration dates | 2025-02 |
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 for recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0875-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.