Mylan Institutional LLC recalls Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL
Mylan recalls Tranexamic Acid Injection vials due to label mix-up with Amiodarone HCl. Cartons labeled as Tranexamic Acid may contain Amiodarone vials and vice versa. Check NDC 67457-197-00 or 67457-197-10 for affected products.
Lower-risk 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.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling Tranexamic Acid Injection vials because cartons labeled for Tranexamic Acid may contain Amiodarone vials and vice versa. This mix-up could lead to incorrect medication use, especially in medical settings where precise labeling is critical. Read more at govinfonow.com/recall/36834-mylan-tranexamic-acid-injection-recall-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36834-mylan-tranexamic-acid-injection-recall-label-mix-up-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1576-2020
Cite this page
“Mylan Tranexamic Acid Injection Recall: Label Mix-Up Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36834-mylan-tranexamic-acid-injection-recall-label-mix-up-risk. Based on FDA recall #D-1576-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1576-2020%22&limit=1).
Why it’s dangerous
The recall addresses a labeling error where cartons intended for Tranexamic Acid Injection may contain Amiodarone HCl Injection vials and vice versa. This mix-up could result in administering the wrong medication, which is dangerous in medical contexts where precise drug identification is essential.
Who’s affected
Healthcare professionals and patients using Tranexamic Acid Injection for medical procedures. Those handling the vials in clinical settings are most at risk due to potential medication errors.
How to tell if you have this one
Check for cartons labeled as Tranexamic Acid Injection, USP with NDC 67457-197-00 (10 vials) or NDC 67457-197-10 (10 x 10 mL vials). The products were manufactured with lot numbers 191207, 191221, 191223 and expire by 11/2021 or 12/2021.
- Brand
Mylan- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1575-2020 | Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.; Lot #: 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021 | 13,682 cartons | 67457-153-00, 67457-153-03, 67457-153-99, 67457-153-09, 67457-153-18 |
| D-1576-2020 | 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.; Lot #: 191207, 191221, 191223, Exp. 11/2021; 200120 Exp. 12/2021 | 1407 cartons | 67457-197-00, 67457-197-10 |
What to do — step by step
Check Product Label
Verify the NDC code on the carton: 67457-197-00 for single-dose vials or 67457-197-10 for 10 vials per carton.
Questions people ask
Is this product safe to use?
The recall indicates a labeling mix-up risk, so the product should not be used until the issue is resolved. The official notice does not specify if the product is safe after checking the label.
What should I do if I have this product?
The recall does not specify a remedy, so you should check the product label for the NDC code and contact Mylan for further instructions.
How can I tell if I have the recalled product?
Look for cartons labeled as Tranexamic Acid Injection, USP with NDC 67457-197-00 or 67457-197-10, manufactured with lot numbers 191207, 191221, 191223, expiring by 11/2021 or 12/2021.
Contact Mylan
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-1576-2020 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-1576-2020 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1576-2020 (August 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1576-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.