Class III · Low risk
Tranexamic Acid USP Tablets
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Is Tranexamic Acid recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Tranexamic Acid (9 total). Check the affected lots below.
Most common reason: Sterility / contamination (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tranexamic Acid. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tranexamic Acid recalls on record
none so far in 2026; 9 on record, newest first
Class III · Low risk
Lysteda (tranexamic acid)
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class I · High risk
Tranexamic Acid Injection
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.
Class II · Moderate risk
Tranexamic Acid active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Tranexamic Acid Injection USP
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Class II · Moderate risk
DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
WB-Tranexamic acid
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
TRANEXAMIC ACID* 2 g/75 mL SOLUTION
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.