FDA Drug recall D-0126-2024
Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc.,…
- FDA Drug
- Class III
- terminated
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class III recall of Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc.,… by Vistapharm, citing failed Excipient Specifications: high content of ethylene glycol (EG).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0126-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-10-17 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vistapharm |
| Distribution | US |
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
Failed Excipient Specifications: high content of ethylene glycol (EG)
Identifiers
| code_info | Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0126-2024%22
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