Class II · Moderate risk
Aminocaproic Acid
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Aminocaproic Acid Oral Solution
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Excipient Specifications: high content of ethylene glycol (EG)
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Affected NDC
66689-0330-08
Compare with the code on your package — it is the most precise check available.
Drug: Aminocaproic
- Recalling firm
- VistaPharm LLC
- NDC code
- 66689-330-08
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0126-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Aminocaproic recalls
See all
Class II · Moderate risk
Aminocaproic Acid active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Aminocaproic Acid 0.5mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Aminocaproic Acid 250 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Other recalls by VistaPharm LLC
All 2023 recalls
Class III · Low risk
Mycophenolate Mofetil for Oral Suspension
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class I · High risk
Sucralfate Oral Suspension
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class II · Moderate risk
Sucralfate Oral Suspension 1g per 10mL
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Class II · Moderate risk
Pyridostigmine Bromide Oral Solution
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
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