Lysteda — Class III drug recall D-0871-2023
Terminated recall by Amring Pharmaceuticals Inc, reported 2023-06-21, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
| Recall number | D-0871-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amring Pharmaceuticals Inc, Berwyn, PA, United States |
| Recall initiated | 2023-06-12 |
| Classified | 2023-06-14 |
| Reported by FDA | 2023-06-21 |
| Terminated | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 48,989 bottles |
| Reason classes | specification failure |
| NDC | 69918-0301, 69918-0301-30 |
| Lot numbers | 09/25, X220317A, X220318A |
Product
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
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-0871-2023. 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.