CLASS I Drug recall · Reported 9 Sep 2020 · FDA Enforcement Report
Tranexamic Acid Injection, USP, 1000 mg recalled by Mylan Institutional
Mylan Institutional is recalling Tranexamic Acid Injection, USP, 1000 mg/ (100 mg/mL) Single-Dose Vial (, distributed nationwide in the US. The recall was initiated on 17 Aug 2020 and the FDA has classified it as Class I.
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-1576-2020
- FDA event ID
- 86247
- Recalling firm
- Mylan Institutional, Rockford, IL
- Brand
- Tranexamic Acid
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Aug 2020
- FDA classified
- 11 Sep 2020
- Reported
- 9 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Aug 2020 | Recall initiated by company | |
| 9 Sep 2020 | Published in enforcement report | +23 days |
| 11 Sep 2020 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Which lots are affected?
Lot #: 191207, 191221, 191223, Exp. 11/2021; 200120 Exp. 12/2021
Where was it sold?
Nationwide
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 products in this recall event
1 other product · FDA event 86247| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride | Mylan Institutional | Packaging Defects | Nationwide |
More recalls from Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
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 | 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 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 |