CLASS III Drug recall · Reported 21 Jun 2023 · FDA Enforcement Report
Lysteda (tranexamic acid) USP Tablets, 650 mg recalled
Amring Pharmaceuticals is recalling Lysteda (tranexamic acid) USP Tablets, 650 mg per, distributed nationwide in the US. The recall was initiated on 12 Jun 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0871-2023
- FDA event ID
- 92458
- Recalling firm
- Amring Pharmaceuticals, Berwyn, PA
- Brand
- Tranexamic Acid
- Manufacturer
- Nordic Pharma, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Jun 2023
- FDA classified
- 14 Jun 2023
- Reported
- 21 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 12 Jun 2023 | Recall initiated by company | |
| 14 Jun 2023 | Classified by FDA | +2 days |
| 21 Jun 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Which lots are affected?
Lots: X220317A and X220318A, exp. date 09/25
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Tranexamic Acid recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tranexamic Acid USP Tablets, 650 mg Unit Dose recalled by AVKARETranexamic Acid | Avkare | Potency & Assay | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Tranexamic Acid Injection, USP, 1000 mg recalled by Mylan InstitutionalTranexamic Acid | Mylan Institutional | Packaging Defects | Nationwide |
| Drug | CLASS II | Tranexamic Acid Injection USP, 1000mg/ vial recalled | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Tranexamic Acid* Solution recalled by Specialty Medicine | Specialty Medicine Compounding Pharmacy | Sterility | MI |