CLASS III Drug recall · Reported 6 Dec 2023 · FDA Enforcement Report
Aminocaproic Acid Oral Solution/mL recalled by VistaPharm
VistaPharm is recalling Aminocaproic Acid Oral Solution/mL, distributed nationwide in the US. The recall was initiated on 17 Oct 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0126-2024
- FDA event ID
- 93261
- Recalling firm
- VistaPharm, Largo, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Oct 2023
- FDA classified
- 28 Nov 2023
- Reported
- 6 Dec 2023
- Type
- Voluntary: Firm initiated
- Reason category
- Packaging Defects
Timeline
| 17 Oct 2023 | Recall initiated by company | |
| 28 Nov 2023 | Classified by FDA | +42 days |
| 6 Dec 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Excipient Specifications: high content of ethylene glycol (EG)
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed Excipient Specifications: high content of ethylene glycol (EG)
Which lots are affected?
Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from VistaPharm
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalled | VistaPharm | Other | Nationwide |
| Drug | CLASS I | Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate | VistaPharm | Other Bacterial Contamination | Nationwide |
| Drug | CLASS II | Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobazam Oral Suspension 2.5 mg/mL recalled by VistaPharm | VistaPharm | Potency & Assay | Nationwide |
Other Aminocaproic Acid recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Aminocaproic Acid, USP (6-Aminohexanoic Acid) active recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia recalled | Lowlite Investments | Sterility | Nationwide |
| Drug | CLASS II | Aminocaproic Acid 250 mg/ml Injection recalled by Lowlite Investments | Lowlite Investments | Sterility | Nationwide |