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.
Other recalls by Vistapharm
- Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#6…
FDA Drug · Class III · 2023-11-15 · Vistapharm - Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPh…
FDA Drug · Class I · 2023-10-25 · Vistapharm - Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm,…
FDA Drug · Class II · 2023-09-20 · Vistapharm - Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689…
FDA Drug · Class II · 2022-11-02 · Vistapharm - Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc
FDA Drug · Class II · 2022-01-26 · Vistapharm
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0126-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.