Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Aminocaproic Acid Oral Solution Recalled by VistaPharm LLC Due to Failed Excipient Specifications: high content of ethylene glycol...

Date: October 17, 2023
Company: VistaPharm LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact VistaPharm LLC directly.

Affected Products

Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08

Quantity: Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottl

Why Was This Recalled?

Failed Excipient Specifications: high content of ethylene glycol (EG)

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About VistaPharm LLC

VistaPharm LLC has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report