Aminocaproic Acid Oral Solution — Class III drug recall D-0126-2024
Terminated recall by VistaPharm LLC, reported 2023-12-06, distributed nationwide. Failed Excipient Specifications: high content of ethylene glycol (EG)
| Recall number | D-0126-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm LLC, Largo, FL, United States |
| Recall initiated | 2023-10-17 |
| Classified | 2023-11-28 |
| Reported by FDA | 2023-12-06 |
| Terminated | 2024-07-26 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination |
| NDC | 66689-0330-08 |
| Lot numbers | 22ZKY1, 22ZMC1, 22ZTP1, 23ZAD1 |
| Expiration dates | 2023-11-27, 2023-12-21, 2024-03-29, 2024-07-07 |
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0126-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.