# FDA recall D-0126-2024

> **VistaPharm LLC** · Class III · drug recall initiated 2023-10-17.

## Product

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

## Reason for recall

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

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0126-2024
- **Recalling firm:** VistaPharm LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-10-17
- **Report date:** 2023-12-06
- **Termination date:** 2024-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Largo, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0126-2024

## Citation

> AI Analytics. FDA recall D-0126-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0126-2024. Source: US FDA. Licensed CC0.

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