CLASS III ONGOING Drug recall · Reported 21 Jun 2023 · FDA Enforcement Report
Tranexamic Acid USP Tablets, 650 mg Unit Dose recalled by AVKARE
Avkare is recalling Tranexamic Acid USP Tablets, 650 mg Unit Dose, distributed nationwide in the US. The recall was initiated on 13 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-0875-2023
- FDA event ID
- 92535
- Recalling firm
- Avkare, Pulaski, TN
- Brand
- Tranexamic Acid
- Manufacturer
- AvPAK
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 13 Jun 2023
- FDA classified
- 15 Jun 2023
- Reported
- 21 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 13 Jun 2023 | Recall initiated by company | |
| 15 Jun 2023 | Classified by FDA | +2 days |
| 21 Jun 2023 | Published in enforcement report | +6 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
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
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?
Lot: 44286 Exp. 02/2025
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.
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|---|---|---|---|---|---|
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Other Tranexamic Acid recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lysteda (tranexamic acid) USP Tablets, 650 mg recalledTranexamic Acid | Amring Pharmaceuticals | 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 |